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Service and Quality Beyond Compliance
Service and Quality Beyond Compliance

Service and Quality Beyond Compliance

Bilcare GCS Overview

Bilcare GCS Overview An international organization providing the worldwide pharmaceutical industry with excellence in

An international organization providing the worldwide pharmaceutical industry with excellence in formulation development, clinical manufacturing, analytical support, packaging and global distribution of clinical trial supplies.

and global distribution of clinical trial supplies. Our Vision : Transforming Health Outcomes –Touching Lives

Our Vision: Transforming Health Outcomes –Touching Lives

Our Values: Speed. Innovation. Happiness.

Why Bilcare GCS?

Why Bilcare GCS? TRUST COMMITMENT AND FACE Flexibility • IN -Sourcing • Geographic Locations • Quantity
TRUST
TRUST

COMMITMENT AND FACE

Flexibility

IN-Sourcing

Geographic

Locations

Quantity /

Capacity

Speed of

Turnaround

Delivery Beyond

Compliance

Project Mgmt

Contract Mgmt

Integrated

Quality

Assurance

System

Integration

Knowledge

One Stop Shop

for Clinical Supplies

Deep Customer

Knowledge and

Relationship

Focus

Experience

Technology

Optima

Blister Pack

Design

Global Labeling

System

IVRS – Next-Gen

Compliance

Unique

India Research

Academy

Dedicated India

Campus

Bilcare History 2008 – – 2007 – 2006 – 2005 2005 2002 – 1982 –

Bilcare History

2008 – – 2007 – 2006 – 2005 2005 2002 – 1982 –
2008
2007
2006
2005
2005
2002
1982

Bilcare GCS Americas Completes Packaging Suites; Expands Phase III Manufacturing Capabilities Bilcare GCS Asia (India) Completes Logistics and Label Operations Expansions

Bilcare Research Academy Establishes Alliance with the Association of Clinical Research Professionals (ACRP)

Bilcare GCS Europe Clinical Supplies Facility Acquired

– Bilcare GCS Asia (India) Clinical Supplies Facility Complete

– Bilcare GCS Americas Clinical Supplies Facility Acquired

Singapore Facility Begins Operations

Bilcare Founded, Pune India

Bilcare GCS Global Facilities

Bilcare GCS Global Facilities
Bilcare GCS Global Facilities
Bilcare GCS Global Facilities
Bilcare GCS Global Facilities

Global Facilities – Americas

Bilcare GCS Americas

Locations

300 Kimberton Rd. Phoenixville, PA 19460

1041 W. Bridge St. Phoenixville, PA 19460

DEA Licensed for Controlled Substances

FDA Registered Facility

Facilities 26 Production Suites Total

Kimberton Rd.

Administrative Offices 10 Primary and 12 Secondary Production Suites Warehouse

W. Bridge St.

Administrative Offices 4 Secondary Production Suites Warehouse

ndary Production Suites Warehouse – W. Bridge St. Administrative Offices 4 Secondary Production Suites Warehouse
ndary Production Suites Warehouse – W. Bridge St. Administrative Offices 4 Secondary Production Suites Warehouse
ndary Production Suites Warehouse – W. Bridge St. Administrative Offices 4 Secondary Production Suites Warehouse
ndary Production Suites Warehouse – W. Bridge St. Administrative Offices 4 Secondary Production Suites Warehouse

Global Facilities – Europe

Bilcare GCS Europe

Location Waller House Elvicta Business Park Crickhowell, Powys NP8 1DF Wales, UK

MHRA Licensed Facility

Facilities 14 Production Suites Total

Couzens Building

Administrative Offices Production Suite – 4 Suites (Primary/Secondary)

Waller House

Administrative Offices Production Suite – 10 Suites (Primary/Secondary) Warehouse

– Waller House Administrative Offices Production Suite – 10 Su ites (Primary/Secondary) Warehouse
– Waller House Administrative Offices Production Suite – 10 Su ites (Primary/Secondary) Warehouse
– Waller House Administrative Offices Production Suite – 10 Su ites (Primary/Secondary) Warehouse
– Waller House Administrative Offices Production Suite – 10 Su ites (Primary/Secondary) Warehouse

Global Facilities – Europe

Expansion: Bilcare GCS Europe

Expansion 2009 Storage and Distribution

Secure Drug Storage & Returns, Ambient / CRT / Refrigerated / Frozen

Yielding 1,000 Additional Pallet Locations

Control Substances Secure Vaults

Secure Warehousing Bulk and Critical Components

Additional Pallet Locations • Control Substances Secure Vaults • Secure Warehousing Bulk and Critical Components
Additional Pallet Locations • Control Substances Secure Vaults • Secure Warehousing Bulk and Critical Components
Additional Pallet Locations • Control Substances Secure Vaults • Secure Warehousing Bulk and Critical Components
Additional Pallet Locations • Control Substances Secure Vaults • Secure Warehousing Bulk and Critical Components

Global Facilities – Asia India Facility

Bilcare GCS Asia – India

Location 307,1028 Shiroli, Rajgurunagar, Pune 411030 India

125 Acre Campus

Licensed for Controlled Substances

Facilities 11 Production Suites Total

Administrative Offices

4 Primary and 7 Secondary Production Suites

Warehouse

11 Production Suites Total – Administrative Offices – 4 Primary and 7 Secondary Production Suites –
11 Production Suites Total – Administrative Offices – 4 Primary and 7 Secondary Production Suites –
11 Production Suites Total – Administrative Offices – 4 Primary and 7 Secondary Production Suites –
11 Production Suites Total – Administrative Offices – 4 Primary and 7 Secondary Production Suites –

Global Facilities – Asia India Facility

Expanded Capabilities Bilcare GCS Asia – India

Operations

New Label Control Facilities

Storage and Distribution

Control Substances Secure Vaults

Secure Warehousing Bulk and Critical Components

Secure Drug Storage, Ambient / CRT / Refrigerated / Frozen

Greater Asia Logistics Operations

Components • Secure Drug Storage, Ambient / CRT / Refrigerated / Frozen • Greater Asia Logistics
Components • Secure Drug Storage, Ambient / CRT / Refrigerated / Frozen • Greater Asia Logistics
Components • Secure Drug Storage, Ambient / CRT / Refrigerated / Frozen • Greater Asia Logistics
Components • Secure Drug Storage, Ambient / CRT / Refrigerated / Frozen • Greater Asia Logistics

Global Facilities – Asia Singapore Facility

Bilcare GCS Asia – Singapore

Location 52, Changi South Street 1 Singapore 486161

GMP Certified Facility

Highest Standard Facility in Asia

Facilities

Administrative Offices

2 Secondary Production Suites

Warehouse

Standard Facility in Asia • Facilities – Administrative Offices – 2 Secondary Production Suites – Warehouse
Standard Facility in Asia • Facilities – Administrative Offices – 2 Secondary Production Suites – Warehouse
Standard Facility in Asia • Facilities – Administrative Offices – 2 Secondary Production Suites – Warehouse
Standard Facility in Asia • Facilities – Administrative Offices – 2 Secondary Production Suites – Warehouse

Bilcare GCS Global Capabilities

Bilcare GCS Global Capabilities You Project Management Clinical Research & Development Clinical Manufacturing

You

Bilcare GCS Global Capabilities You Project Management Clinical Research & Development Clinical Manufacturing
Bilcare GCS Global Capabilities You Project Management Clinical Research & Development Clinical Manufacturing
Project Management
Project Management
Clinical Research & Development
Clinical
Research &
Development
Clinical Manufacturing Packaging & Labeling
Clinical
Manufacturing
Packaging &
Labeling
Global Logistics & Supply Chain Management
Global
Logistics &
Supply
Chain
Management
IVRS IWRS
IVRS
IWRS
Global Comparator Sourcing
Global
Comparator
Sourcing
IN-Sourcing Offsite Clinical Supplies Operations
IN-Sourcing
Offsite
Clinical
Supplies
Operations
IWRS Global Comparator Sourcing IN-Sourcing Offsite Clinical Supplies Operations Quality Foundation & Services
IWRS Global Comparator Sourcing IN-Sourcing Offsite Clinical Supplies Operations Quality Foundation & Services

Quality Foundation & Services

IWRS Global Comparator Sourcing IN-Sourcing Offsite Clinical Supplies Operations Quality Foundation & Services

Global Capabilities – Project Management

Global Capabilities – Project Management Bilcare N. America Project Management Bilcare Europe Project Management
Bilcare N. America Project Management Bilcare Europe Project Management You Bilcare Bilcare Asia Strategic
Bilcare
N. America
Project
Management
Bilcare
Europe
Project
Management
You
Bilcare
Bilcare
Asia
Strategic
Project
Management
Management

Global Capabilities – Project Management

Global Capabilities – Project Management Global Experience Proactive Lessons Communication Learned Bilcare GCS
Global Experience Proactive Lessons Communication Learned Bilcare GCS Project Management Functional Continuous
Global
Experience
Proactive
Lessons
Communication
Learned
Bilcare GCS
Project
Management
Functional
Continuous
Expertise
Training

Global Capabilities – Project Management

Global Capabilities – Project Management Bilcare GCS Project Management The Key to Your Project’s Success

Bilcare GCS Project Management

The Key to Your Project’s Success

Communication

Customized Communication Plan

Kick-Off Meetings

Team Meetings

Measuring Success

Overall Performance

On-time Production

On-time Shipments and Logistics

Processing of Import/Export Materials and

Supplies Evaluation of Bilcare Locations in General and

Specific Functions Gantt Charts

Dedicated Project Management

Globally and Site Specific (Bilcare Locations)

Label Control Teams

Logistics Teams

Lessons Learned

Review of Goals Reached & Attempted

Review of Metrics in Reaching Goals -

Performance Evaluation of Communication

Gantt Charts

Global Capabilities – Clinical R&D

Global Capabilities – Clinical R&D Clinical Research & Development Analytical Formulation Services
Global Capabilities – Clinical R&D Clinical Research & Development Analytical Formulation Services
Global Capabilities – Clinical R&D Clinical Research & Development Analytical Formulation Services
Global Capabilities – Clinical R&D Clinical Research & Development Analytical Formulation Services
Clinical Research & Development Analytical Formulation Services Development
Clinical
Research &
Development
Analytical
Formulation
Services
Development
Capabilities – Clinical R&D Clinical Research & Development Analytical Formulation Services Development
Capabilities – Clinical R&D Clinical Research & Development Analytical Formulation Services Development
Capabilities – Clinical R&D Clinical Research & Development Analytical Formulation Services Development

Global Capabilities – Analytical

Bilcare GCS Analytical Services

GMP qualified scientists oversee comprehensive testing of your materials. We take extra steps to ensure that your products comply with regulatory standards.

Seven Analytical Laboratories

Spectroscopy Laboratory

Dissolution Laboratory

Chromatography Laboratory

Physical Testing Laboratory

Sample Preparation Laboratory

Development Laboratories

Stability Storage Suite

Physical Testing Laboratory • Sample Preparation Laboratory • Development Laboratories • Stability Storage Suite
Physical Testing Laboratory • Sample Preparation Laboratory • Development Laboratories • Stability Storage Suite
Physical Testing Laboratory • Sample Preparation Laboratory • Development Laboratories • Stability Storage Suite
Physical Testing Laboratory • Sample Preparation Laboratory • Development Laboratories • Stability Storage Suite

Global Capabilities – Analytical

Bilcare GCS Analytical Services

Our dedicated personnel provide technical support during each phase of your product’s development and manufacturing.

Analytical Laboratory Testing

HPLC Analysis

Content Uniformity Studies

Chromatographic Impurity Profiling

Performance Type Testing (e.g. Friability, Hardness and Dissolution Testing)

Identification Testing

Release Testing

Stability and Storage Testing

Cleaning Verification / Validation

Identification Testing • Release Testing • Stability and Storage Testing • Cleaning Verification / Validation
Identification Testing • Release Testing • Stability and Storage Testing • Cleaning Verification / Validation
Identification Testing • Release Testing • Stability and Storage Testing • Cleaning Verification / Validation
Identification Testing • Release Testing • Stability and Storage Testing • Cleaning Verification / Validation

Global Capabilities – Analytical

Bilcare GCS Analytical Services

Our dedicated personnel provide technical support during each phase of your product’s development and manufacturing.

Analytical Laboratory Testing (Continued)

Accelerated Drug Stressing

Dissolution Profile Testing

Extractable Studies for Parenteral Products

Competitor Analysis for Unbiased De-Formulation

Hygroscopicity Studies

Method Development and Validation for All Phases and All Components in Development of the following:

Drug Substance

Non-Compendial Excipients

Drug Product

Process Development Support

of the following: • Drug Substance • Non-Compendial Excipients • Drug Product • Process Development Support
of the following: • Drug Substance • Non-Compendial Excipients • Drug Product • Process Development Support
of the following: • Drug Substance • Non-Compendial Excipients • Drug Product • Process Development Support
of the following: • Drug Substance • Non-Compendial Excipients • Drug Product • Process Development Support

Global Capabilities – Analytical

Bilcare GCS Analytical Services

Our dedicated personnel provide technical support during each phase of your product’s development and manufacturing.

Analytical Laboratory Testing (Continued)

Reference Standard Qualification Testing

Stability Study Protocol Design (ICH and Custom)

Mapped Environmental Chambers Including:

25°C/60% RH

30°C/65% RH

40°C/75% RH

25°C/40% RH

40°C/25% RH

5°C

Photo Stability

• 25°C/60% RH • 30°C/65% RH • 40°C/75% RH • 25°C/40% RH • 40°C/25% RH •
• 25°C/60% RH • 30°C/65% RH • 40°C/75% RH • 25°C/40% RH • 40°C/25% RH •
• 25°C/60% RH • 30°C/65% RH • 40°C/75% RH • 25°C/40% RH • 40°C/25% RH •
• 25°C/60% RH • 30°C/65% RH • 40°C/75% RH • 25°C/40% RH • 40°C/25% RH •

Global Capabilities – Analytical

Bilcare GCS Analytical Services

Bilcare GCS Americas can be utilized to support Analytical Research and Development for both EU and Asia facilities.

GLOBALCAPABILITIES GLOBALCAPABILITIES

AMERICAS AMERICAS

EUROPE EUROPE

ASIA ASIA

Analytical&ResearchServices

Analytical&ResearchServices

AnalyticalLaboratory

AnalyticalLaboratory

1

1

ReleaseTesting

ReleaseTesting

2

2

Stability

Stability

2

2

2 2

MethodDevelopment

MethodDevelopment

1

1

1 1

CleaningVerification

CleaningVerification

ControlledSubstanceManagement

ControlledSubstanceManagement

1

1

1 1

- Fully Supported 1 - Achieved with Support from Bilcare GCS Americas 2 - Achieved with Support from Bilcare GCS Americas or Local Third Party

with Support from Bilcare GCS Americas 2 - Achieved with Support from Bilcare GCS Americas or
with Support from Bilcare GCS Americas 2 - Achieved with Support from Bilcare GCS Americas or
with Support from Bilcare GCS Americas 2 - Achieved with Support from Bilcare GCS Americas or
with Support from Bilcare GCS Americas 2 - Achieved with Support from Bilcare GCS Americas or

Global Capabilities – Formulation

Bilcare GCS Formulation Development

The Bilcare team of formulation specialists is always ready to provide you with expeditious innovative formulations for your clinical trials.

Pre-Formulation Services

Chemical Compatibility & Reactivity to Packaging Substrates

Physical Properties & Product Characterization

Accelerated Degradation

API-Excipient Interaction Studies

pKa Determination

Hygroscopicity Studies

Photostability of API

Prototype Evaluations

Reverse Engineering

Determination • Hygroscopicity Studies • Photostability of API • Prototype Evaluations • Reverse Engineering
Determination • Hygroscopicity Studies • Photostability of API • Prototype Evaluations • Reverse Engineering
Determination • Hygroscopicity Studies • Photostability of API • Prototype Evaluations • Reverse Engineering
Determination • Hygroscopicity Studies • Photostability of API • Prototype Evaluations • Reverse Engineering

Global Capabilities – Formulation

Bilcare GCS Formulation Development

Following the determination of the appropriate composition, the Bilcare formulation staff focus their interest on the development of the process for making your clinical trial material.

Formulation Development

Phase I-IV Formulation Development and Reformulations

Determine Blending Times for Tableting & Encapsulation and Analysis of Characteristics (Blending Time, Bulk Density, Content Uniformity, and Flow Characteristics)

Overencapsulation and Comparator Product Blinding

Develop Matching Placebo Product / Comparator Supplies

Develop Both Ethical and Over-The-Counter Products: tablets (immediate and controlled release), powders, liquids, suspensions, emulsions, creams and ointments, lotions

Develop Line Extensions in the Above Dosage Forms

liquids, suspensions, emulsions, crea ms and ointments, lotions • Develop Line Extensions in the Above Dosage
liquids, suspensions, emulsions, crea ms and ointments, lotions • Develop Line Extensions in the Above Dosage
liquids, suspensions, emulsions, crea ms and ointments, lotions • Develop Line Extensions in the Above Dosage
liquids, suspensions, emulsions, crea ms and ointments, lotions • Develop Line Extensions in the Above Dosage

Global Capabilities – Formulation

Bilcare GCS Formulation Development

Bilcare has the technical expertise, experience, and range of technical support services to help you achieve your clinical trial goals, troubleshoot existing products or improve current products.

Technical Services

Experienced Professionals to Troubleshoot Commercial Products

Formulation Optimization & Evaluation of New Raw Materials in Existing Products

Technical Transfer of Products from R&D to Production Facilities

Process Optimization & Scale-up and Assessment of Current Products & Recommendations for Improvements to Modernize Existing Manufacturing / Clinical Supplies Processes

Products & Recommendations fo r Improvements to Modernize Existing Manufacturing / Clinical Supplies Processes
Products & Recommendations fo r Improvements to Modernize Existing Manufacturing / Clinical Supplies Processes
Products & Recommendations fo r Improvements to Modernize Existing Manufacturing / Clinical Supplies Processes
Products & Recommendations fo r Improvements to Modernize Existing Manufacturing / Clinical Supplies Processes

Global Capabilities – Formulation

Bilcare GCS Formulation Development

Bilcare GCS Americas can be utilized to support Formulation Development for both EU and Asia facilities.

GLOBALCAPABILITIES GLOBALCAPABILITIES

AMERICAS AMERICAS

EUROPE EUROPE

ASIA ASIA

FormulationDevelopment

FormulationDevelopment

1

1

1

1

ControlledSubstanceManagement

ControlledSubstanceManagement

- Fully Supported 1 - Achieved with Support from Bilcare GCS Americas

ControlledSubstanceManagement - Fully Supported 1 - Achieved with Support from Bilcare GCS Americas
ControlledSubstanceManagement - Fully Supported 1 - Achieved with Support from Bilcare GCS Americas
ControlledSubstanceManagement - Fully Supported 1 - Achieved with Support from Bilcare GCS Americas
ControlledSubstanceManagement - Fully Supported 1 - Achieved with Support from Bilcare GCS Americas

Global Capabilities – Clinical Manufacturing, Packaging & Labeling

Bilcare GCS Clinical Manufacturing

Once a drug has been formulated, Bilcare has manufacturing facilities that can provide fast, efficient and agile manufacturing of solid dosage forms as well as liquids, creams, and ointments.

Clinical Manufacturing Capabilities

Wet or Dry Granulation and Blending

Tablet Compression and Coating

Global Comparator Procurement

Manufacture Clinical Supplies

Blending and Encapsulation

Encapsulation and Over-Encapsulation

Phase I-IV Development and Reformulations

Placebo Manufacturing

Comparator Blinding

and Over-Encapsulation • Phase I-IV Development and Reformulations • Placebo Manufacturing • Comparator Blinding
and Over-Encapsulation • Phase I-IV Development and Reformulations • Placebo Manufacturing • Comparator Blinding
and Over-Encapsulation • Phase I-IV Development and Reformulations • Placebo Manufacturing • Comparator Blinding
and Over-Encapsulation • Phase I-IV Development and Reformulations • Placebo Manufacturing • Comparator Blinding

Global Capabilities – Clinical Manufacturing, Packaging & Labeling

Bilcare GCS Clinical Manufacturing

Our unique approach enables us to support customer requirements for short-term studies as well as large- volume ongoing projects.

Dosage Forms Manufactured

Controlled and Immediate-Release Tablets

Capsules (Multi-Fill, Powder, Solid, Liquid, Semi-Solid, Solid/Liquid Combination Fills)

Powders and Dry Powders

Liquids

Suspensions

Emulsions

Creams & Ointments

Lotions

Fills) • Powders and Dry Powders • Liquids • Suspensions • Emulsions • Creams & Ointments
Fills) • Powders and Dry Powders • Liquids • Suspensions • Emulsions • Creams & Ointments
Fills) • Powders and Dry Powders • Liquids • Suspensions • Emulsions • Creams & Ointments
Fills) • Powders and Dry Powders • Liquids • Suspensions • Emulsions • Creams & Ointments

Global Capabilities – Clinical Manufacturing, Packaging & Labeling

Bilcare GCS Clinical Packaging

We help you select the right packaging solutions, complete production and deliver a final product that meets your high standards through comprehensive packaging research that produces the best, customized and innovative clinical packaging materials.

Primary and Secondary Packaging

Bottling (Solids / Semi-Solids)

Blister Packaging – Any Configuration

Coldform & Thermoform

Tube Filling

Creams

Ointments

Blister Card Sealing and Walleting

Pouching / Powder Filling

Label Application and Kit Assembly

Controlled Substance Packaging (Schedule I – V)

Ambient & Controlled Temp. (Refrigerated / Frozen) Packaging

Controlled Substance Packaging (Schedule I – V) • Ambient & Controlled Temp. (R efrigerated / Froz
Controlled Substance Packaging (Schedule I – V) • Ambient & Controlled Temp. (R efrigerated / Froz
Controlled Substance Packaging (Schedule I – V) • Ambient & Controlled Temp. (R efrigerated / Froz
Controlled Substance Packaging (Schedule I – V) • Ambient & Controlled Temp. (R efrigerated / Froz

Global Capabilities – Clinical Manufacturing, Packaging & Labeling

Bilcare GCS Clinical Labeling

Bilcare provides support with full labeling services and innovations for your product, meeting all of your high standards and expectations. We pay strict attention to global regulatory requirements.

In-House Label Generation, Production

Label Types Produced

Single & Multi-Panel

Single & Multi-Lingual

Randomized & Open

Sequentially Numbered

Variable Text

32 Languages Fully Supported

Code Break & Randomization Generation

Client-Supplied Randomization Fully Supported

21 CFR Part 11 Compliant PRISYM Software for Label Design

• Client-Supplied Randomiz ation Fully Supported • 21 CFR Part 11 Compliant PRIS YM Software for
• Client-Supplied Randomiz ation Fully Supported • 21 CFR Part 11 Compliant PRIS YM Software for
• Client-Supplied Randomiz ation Fully Supported • 21 CFR Part 11 Compliant PRIS YM Software for
• Client-Supplied Randomiz ation Fully Supported • 21 CFR Part 11 Compliant PRIS YM Software for

Global Capabilities – Clinical Manufacturing, Packaging & Labeling

The Bilcare GCS Integrated Process

Our clinical manufacturing, packaging & labeling capabilities fall under one powerful comprehensive path in meeting all of your clinical project needs.

The Benefits

A Single Point of Contact

A Single Audit for You to Complete and Sustain

Single Format and Management of Batch Records and Documentation

Minimized Manufacturing Timeline, Risk and Documentation Delays that can Occur When Transferring Materials Between Multiple Vendor Strategies

Our Quality Process Ensures that We Have Produced:

The Right Product

In the Right Container

With the Correct Label

Process Ensures that We Have Produced: • The Right Product • In the Right Container •
Process Ensures that We Have Produced: • The Right Product • In the Right Container •
Process Ensures that We Have Produced: • The Right Product • In the Right Container •
Process Ensures that We Have Produced: • The Right Product • In the Right Container •

Global Capabilities – Clinical Manufacturing, Packaging & Labeling

Bilcare GCS Clinical Manufacturing, Packaging & Labeling

Our global clinical services expertise supports customers in every decision-making process.

GLOBAL CAPABILITIES

GLOBAL CAPABILITIES

AMERICAS

AMERICAS

EUROPE

EUROPE

ASIA

ASIA

Clinical Manufacturing

Clinical Manufacturing

Solid, Liquid, Creams

1

1

Solid, Liquid, Creams

Encapsulation

1

1

Encapsulation

Over-encapsulation

1

1

Over-encapsulation

Controlled Substance Management

1

1

Controlled Substance Management

Packaging

Packaging

Bottling

Bottling

High Speed Bottling

2

2

2

2

High Speed Bottling

Blistering

Blistering

High Speed Blistering

1

1

High Speed Blistering

Pouching

1

1

Pouching

Tube Filling

1

1

Tube Filling

Blister Carding

Blister Carding

Label Application and Kit Assembly

Label Application and Kit Assembly

Controlled Substance Management

Controlled Substance Management

Comparator Sourcing & Acquisition

Labeling

Comparator Sourcing & Acquisition

Labeling

Label design

Label design

Label production

Label production

Label procurement

Label procurement

- Fully Supported 1 - Achieved with Support from Bilcare GCS Americas and/or Europe 2 - Achieved with Support from Bilcare GCS Americas

- Achieved with Support from Bilcare GCS Americas and/or Europe 2 - Achieved with Support from
- Achieved with Support from Bilcare GCS Americas and/or Europe 2 - Achieved with Support from
- Achieved with Support from Bilcare GCS Americas and/or Europe 2 - Achieved with Support from
- Achieved with Support from Bilcare GCS Americas and/or Europe 2 - Achieved with Support from

Global Capabilities – Logistics & Supply Chain Management

Bilcare GCS Global Logistics & Supply Chain Management

Bilcare can store and ship your materials to sites worldwide under any array of conditions. You can rely on our proven global network to have the right product to the right site under the right timeline.

Our Advantage

Customized Logistics Solutions

Import / Export of Clinical Trial Material

Depot Management

Conditions Supported: Ambient, Refrigerated (2-8 ˚ C) & Frozen (-20˚ C, -70 ˚ C, -80 ˚ C)

Cold Chain Solutions

Global Distribution Management

Specialized Logistics Project Management

Controlled Substance Management

• Global Distribution Management • Specialized Logistics Project Management • Controlled Substance Management
• Global Distribution Management • Specialized Logistics Project Management • Controlled Substance Management
• Global Distribution Management • Specialized Logistics Project Management • Controlled Substance Management
• Global Distribution Management • Specialized Logistics Project Management • Controlled Substance Management

Global Capabilities – Logistics & Supply Chain Management

Bilcare GCS Global Logistics & Supply Chain Management

In addition to our vast global storage & distribution capabilities, we provide reconciliation and destruction services for returned goods with optimal accuracy and efficiency.

Returns & Destruction

Customer and Project Specific Returns and Reconciliation Protocols

Ample and Secured Storage

Regulatory Compliance and Documentation Support

Updated and Complete Documentation on Destruction

Storage • Regulatory Compliance and Documentation Support • Updated and Complete Documentation on Destruction
Storage • Regulatory Compliance and Documentation Support • Updated and Complete Documentation on Destruction
Storage • Regulatory Compliance and Documentation Support • Updated and Complete Documentation on Destruction
Storage • Regulatory Compliance and Documentation Support • Updated and Complete Documentation on Destruction

Global Capabilities – Logistics & Supply Chain Management

Global Capabilities – Logistics & Supply Chain Management Global Supply Chain Depot Network

Global Supply Chain Depot Network

Global Capabilities – Logistics & Supply Chain Management Global Supply Chain Depot Network

Global Capabilities – Logistics & Supply Chain Management

Bilcare GCS Global Logistics & Supply Chain Management

There are many smart reasons for using Bilcare Global Logistics services to achieve success in your clinical trials needs.

GLOBAL GLOBAL CAPABILITIES CAPABILITIES

AMERICAS AMERICAS

EUROPE EUROPE

ASIA ASIA

Global Logistics &Distribution

Global Logistics &Distribution

Cold ChainShipping

Cold ChainShipping

°

     

Ambient (15-25 C)

°

Ambient (15-25 C)

°

     

Refrigerated(2-8 C)

°

Refrigerated(2-8 C)

°

     

Frozen(-20 C)

°

Frozen(-20 C)

°

°

     

DeepFreeze(-70 C/-80 C)

°

°

DeepFreeze(-70 C/-80 C)

Inventory Management

Inventory Management

Returns Returns &Destruction &Destruction

Controlled Substance Management

Controlled Substance Management

- Fully Supported

• • Controlled Substance Management Controlled Substance Management - Fully Supported
• • Controlled Substance Management Controlled Substance Management - Fully Supported
• • Controlled Substance Management Controlled Substance Management - Fully Supported
• • Controlled Substance Management Controlled Substance Management - Fully Supported

Global Capabilities – IVR / IWR Services

Global Capabilities – IVR / IWR Services Bilcare GCS IVR / IWR Services There are a

Bilcare GCS IVR / IWR Services

There are a number of compelling benefits for using the Bilcare GCS IVRS/IWRS for a more streamlined and successful clinical trial.

Primary Benefits

24 Hours a Day / 7 Days a Week

Streamlined Setup and Validation of New Studies

Accelerated Process for Moving from Protocol to User Acceptance Testing (UAT)

Extensive Experience and Guidance

System Flexibility

Use Statistical Scheme

Balance at Any Level

Can Accommodate Stratifications

and Guidance System Flexibility • Use Statistical Scheme • Balance at Any Level • Can Accommodate
and Guidance System Flexibility • Use Statistical Scheme • Balance at Any Level • Can Accommodate
and Guidance System Flexibility • Use Statistical Scheme • Balance at Any Level • Can Accommodate

Global Capabilities – IVR / IWR Services

Global Capabilities – IVR / IWR Services Bilcare GCS IVR / IWR Services Part of the

Bilcare GCS IVR / IWR Services

Part of the Bilcare GCS Clinical Supply Chain is an Interactive Voice/Web Response System.

Access via Phone or Web

User Friendly and Easy to Use

Data Entry Direct from Source

Toll-Free Phone Lines

Secure Entry

Available 24/7

Multilingual

Use • Data Entry Direct from Source • Toll-Free Phone Lines • Secure Entry • Available
Use • Data Entry Direct from Source • Toll-Free Phone Lines • Secure Entry • Available
Use • Data Entry Direct from Source • Toll-Free Phone Lines • Secure Entry • Available

Global Capabilities – IVR / IWR Services

Global Capabilities – IVR / IWR Services Bilcare GCS IVR / IWR Services There are a

Bilcare GCS IVR / IWR Services

There are a number of compelling benefits for using the Bilcare GCS IVRS/IWRS for a more streamlined and successful clinical trial.

Automated System

Automates Patient Enrollment and Randomization

Captures Data

E-Diaries

Tracks Clinical Supplies Inventory and Automatically Re-Supplies Clinical Trial Materials

Ensures No Interruptions to Enrollment Due to Clinical Supplies Problems

Streamlined Setup and Validation of New Studies

Accelerated Process for Moving from Protocol to User Acceptance Testing (UAT)

Setup and Validation of New Studies • Accelerated Process for Moving from Protocol to User Acceptance
Setup and Validation of New Studies • Accelerated Process for Moving from Protocol to User Acceptance
Setup and Validation of New Studies • Accelerated Process for Moving from Protocol to User Acceptance

Global Capabilities – IVR / IWR Services

Global Capabilities – IVR / IWR Services Bilcare GCS IVR / IWR Services Bilcare GCS’ system

Bilcare GCS IVR / IWR Services

Bilcare GCS’ system is fully customizable and flexible to ensure that all of your clinical trial needs are met without any interruption.

Study Material Management

At Warehouse

At Depots

At Sites

Individual Patient Assignments

Shipments

Phone or Web Management

Site Initiation

Patient Enrollment

Randomization

Drug Management

Shipments Phone or Web Management • Site Initiation • Patient Enrollment • Randomization • Drug Management
Shipments Phone or Web Management • Site Initiation • Patient Enrollment • Randomization • Drug Management
Shipments Phone or Web Management • Site Initiation • Patient Enrollment • Randomization • Drug Management

Global Capabilities – IVR / IWR Services

Global Capabilities – IVR / IWR Services Why Bilcare GCS IVR / IWR Services? World-class speed

Why Bilcare GCS IVR / IWR Services?

World-class speed for setup and validation of new studies – less than four weeks from User Requirement Specification (URS) approvals to User Acceptance Testing (UAT) Minimizes Per-Patient Cost of Trial Rapid Scale Out for New Sites, Dial-In Locations (Point of Presence) Easy to Validate, Easy to Purchase, and Easy to Modify Ease of Access to Study Metrics Extremely Flexible Prevents Drug Wastage Prevents Patient Over-Enrollment

Ease of Access to Study Metrics Extremely Flexible Prevents Drug Wastage Prevents Patient Over-Enrollment
Ease of Access to Study Metrics Extremely Flexible Prevents Drug Wastage Prevents Patient Over-Enrollment
Ease of Access to Study Metrics Extremely Flexible Prevents Drug Wastage Prevents Patient Over-Enrollment

Global Capabilities – IVR / IWR Services

Global Capabilities – IVR / IWR Services Bilcare GCS IVR / IWR Services Bilcare GCS IVR

Bilcare GCS IVR / IWR Services

Bilcare GCS IVR / IWR services can be utilized to manage any global study from any location.

GLOBALCAPABILITIES GLOBALCAPABILITIES

AMERICAS AMERICAS

EUROPE EUROPE

ASIA ASIA

IVRS/ IVRS/ IWRS IWRS

Design

Design

1

1 1

1

Management

Management

1

1 1

1

- Fully Supported 1 - Achieved with Support from Bilcare GCS Americas

Management 1 1 1 1 - Fully Supported 1 - Achieved with Support from Bilcare GCS
Management 1 1 1 1 - Fully Supported 1 - Achieved with Support from Bilcare GCS
Management 1 1 1 1 - Fully Supported 1 - Achieved with Support from Bilcare GCS

Global Capabilities – Comparator Sourcing

Global Capabilities – Comparator Sourcing Bilcare GCS Comparator Sourcing Procurement of comparator drugs is often an

Bilcare GCS Comparator Sourcing

Procurement of comparator drugs is often an extremely challenging aspect of implementing clinical studies. Because of Bilcare GCS’ global presence and experience, this aspect is achieved efficiently and effectively on a consistent basis.

Our Global Sourcing Network

Supply Network

Drug Manufacturers Direct

Wholesalers

Established Relationships with Manufacturers and Global Wholesalers

Market Agility: The Ability to Purchase Any Product from Any Global Market

Your Confidentiality in Mind

• Market Agility: The Ability to Purchase Any Product from Any Global Market • Your Confidentiality
• Market Agility: The Ability to Purchase Any Product from Any Global Market • Your Confidentiality
• Market Agility: The Ability to Purchase Any Product from Any Global Market • Your Confidentiality

Global Capabilities – Comparator Sourcing

Global Capabilities – Comparator Sourcing Bilcare GCS Comparator Sourcing Since Bilcare GCS has facilities in North

Bilcare GCS Comparator Sourcing

Since Bilcare GCS has facilities in North America, Europe, and Asia, procurement of comparator drugs can be very efficiently implemented on your company’s behalf for studies around the world.

GLOBALCAPABILITIES GLOBALCAPABILITIES

AMERICAS AMERICAS

EUROPE EUROPE

ASIA ASIA

ComparatorSourcing

ComparatorSourcing

ComparatorSourcing

ComparatorSourcing

ComparatorDistributionMgmt

ComparatorDistributionMgmt

- Fully Supported

ComparatorSourcing • • ComparatorDistributionMgmt ComparatorDistributionMgmt - Fully Supported
ComparatorSourcing • • ComparatorDistributionMgmt ComparatorDistributionMgmt - Fully Supported
ComparatorSourcing • • ComparatorDistributionMgmt ComparatorDistributionMgmt - Fully Supported

Global Capabilities – IN-Sourcing Offsite Clinical Supplies Operations

Bilcare GCS Global IN-Sourcing

Bilcare GCS’ major strength lies in its ability to fully integrate innovative solutions and services throughout a drug’s clinical trial life cycle – Onsite or Offsite. We bring all of our global expertise and experience to you.

Clinical Supplies Operations at Your Site

Staffing and Staff Augmentation

Operations / Production – All Verticals

Complete Project Management

Quality / Regulatory Services

Full Accountability / Maximum Flexibility

The Bilcare GCS Promise Upheld: Service and Quality Beyond Compliance – Regardless of the Location of the Project

• The Bilcare GCS Promise Upheld: Service and Quality Beyond Compliance – Regardless of the Location
• The Bilcare GCS Promise Upheld: Service and Quality Beyond Compliance – Regardless of the Location
• The Bilcare GCS Promise Upheld: Service and Quality Beyond Compliance – Regardless of the Location
• The Bilcare GCS Promise Upheld: Service and Quality Beyond Compliance – Regardless of the Location

Global Capabilities – IN-Sourcing Offsite Clinical Supplies Operations

Bilcare GCS Global IN-Sourcing

Bilcare GCS’ vision and values are carried with us wherever we operate. If your clinical trial needs can not come to us, we can come to you to achieve the success that you are striving for in all of your clinical supplies needs.

GLOBALCAPABILITIES GLOBALCAPABILITIES

AMERICAS AMERICAS

EUROPE EUROPE

ASIA ASIA

IN-Sourcing–OffsiteClinical SuppliesOps.

IN-Sourcing–OffsiteClinical SuppliesOps.

Formulation Development

Formulation Development

   

Analytical &ResearchServices

Analytical &ResearchServices

   

Clinical Manufacturing

Clinical Manufacturing

   

Packaging

Packaging

Labeling

Labeling

IVRS/IWRS IVRS/IWRS

   

Global Logistics&Distribution

Global Logistics&Distribution

QualityAssuranceServices

QualityAssuranceServices

- Fully Supported

Global Logistics&Distribution QualityAssuranceServices QualityAssuranceServices - Fully Supported
Global Logistics&Distribution QualityAssuranceServices QualityAssuranceServices - Fully Supported
Global Logistics&Distribution QualityAssuranceServices QualityAssuranceServices - Fully Supported
Global Logistics&Distribution QualityAssuranceServices QualityAssuranceServices - Fully Supported

Global Capabilities – Quality Foundation & Services

Bilcare GCS Quality Foundation

Bilcare GCS is registered with the DEA as a Manufacturer, Distributor, Exporter, Importer and Analytical Laboratory of Controlled Substances.

Regulatory History

Bilcare GCS Americas

Establishment License (FDA) – No 483s

License

2531012

Last Inspection:

January 2007

DEA Licensing – No Citations / Issues

DEA Manufacturer’s License (I-V)

RB0326923

DEA Distributor License (I-V)

RB0326771

DEA Exporter License (I-V)

RB0326810

DEA Importer License (IIIN, IV)

RB0326822

DEA Analytical License (I-V)

RB0326795

Last DEA Inspection:

September 2006

(IIIN, IV) RB0326822 • DEA Analytical License (I-V) RB0326795 • Last DEA Inspection: September 2006
(IIIN, IV) RB0326822 • DEA Analytical License (I-V) RB0326795 • Last DEA Inspection: September 2006
(IIIN, IV) RB0326822 • DEA Analytical License (I-V) RB0326795 • Last DEA Inspection: September 2006
(IIIN, IV) RB0326822 • DEA Analytical License (I-V) RB0326795 • Last DEA Inspection: September 2006

Global Capabilities – Quality Foundation & Services

Bilcare GCS Quality Foundation

We strive everyday to seek perfection in terms of quality in the eyes of you (our client) and regulatory agencies.

Regulatory History

Bilcare GCS Europe

MHRA Licensed Site Number 12225

MHRA Audit March 3, 2008 – No Critical or Major Observations

Manufacturer’s Authorization (Investigational Medicinal Products)

MA (IMP) 10284

6 named QP’s

Manufacturer’s License (Assembly Only)

AO/10284/1

Manufacturers “Specials” License

MS/10284/1

Wholesale Dealers License

WL/10284/1

Wholesale Dealers (Import) License Home Office Controlled Drugs Licenses

WI/10284/1

Dealers License WL/10284/1 Wholesale Dealers (Im port) License Home Office Contro lled Drugs Licenses WI/10284/1
Dealers License WL/10284/1 Wholesale Dealers (Im port) License Home Office Contro lled Drugs Licenses WI/10284/1
Dealers License WL/10284/1 Wholesale Dealers (Im port) License Home Office Contro lled Drugs Licenses WI/10284/1
Dealers License WL/10284/1 Wholesale Dealers (Im port) License Home Office Contro lled Drugs Licenses WI/10284/1

Global Capabilities – Quality Foundation & Services

Bilcare GCS Quality Foundation

Our Standard Operating Procedures (SOP’s) can be made available for your review during your audit of our facilities. Feel free to schedule an audit or visit to Bilcare soon.

Regulatory History

Bilcare GCS Asia

Controlled Substance License (Storage and Distribution)

Manufacturing License from State FDA

Storage & Distribution License from State FDA

NDPS I License from State FDA

Planned MHRA Inspection to Take Place Soon

& Distribution Li cense from State FDA NDPS I License from State FDA Planned MHRA Inspecti
& Distribution Li cense from State FDA NDPS I License from State FDA Planned MHRA Inspecti
& Distribution Li cense from State FDA NDPS I License from State FDA Planned MHRA Inspecti
& Distribution Li cense from State FDA NDPS I License from State FDA Planned MHRA Inspecti

Global Capabilities – Quality Foundation & Services

Bilcare GCS Quality Services

Bilcare GCS offers QP Services in accordance with the EU requirement that all investigational, medicinal products manufactured or imported by organizations holding a MA IMP have available a Qualified Person to approve and release each batch of IMP for clinical trial use.

QP Services

Audit of Manufacturing Sites Within and Outside the EU

Assessment of Each Batch for Certification Prior to Release. May Include, as appropriate:

Batch records, including control reports

In-process test reports and release reports demonstrating compliance with the product specification file, the order, protocol and randomization code.

reports demonstrating compliance with the product specification file, the order, protocol and randomization code.
reports demonstrating compliance with the product specification file, the order, protocol and randomization code.
reports demonstrating compliance with the product specification file, the order, protocol and randomization code.
reports demonstrating compliance with the product specification file, the order, protocol and randomization code.

Global Capabilities – Quality Foundation & Services

Bilcare GCS Quality Services

QP’s are assigned projects according to their specialized expertise and have personal and legal responsibility as described in the EU Clinical Trial Directive (2001/20/EC) to ensure the investigational products are produced in accordance with EU GMP and the clinical trial authority.

QP Services (Continued)

Production Conditions

The Validation Status of Facilities, Processes & Methods

Examination of Finished Packs

Audit the Results of Any Analyses or Tests Performed after Importation

Stability Reports

The Source and Verification of Conditions of Storage and Shipment

Performed after Importation • Stability Reports • The Source and Verification of Conditions of Storage and
Performed after Importation • Stability Reports • The Source and Verification of Conditions of Storage and
Performed after Importation • Stability Reports • The Source and Verification of Conditions of Storage and
Performed after Importation • Stability Reports • The Source and Verification of Conditions of Storage and

Global Capabilities – Quality Foundation & Services

Bilcare GCS Quality Services

Bilcare has a team of six Qualified Persons (QP’s) with wide experience in the manufacture and supply of Investigational Medicinal Products.

QP Services (Continued)

Audit Reports Concerning the Quality System of the Manufacturer

Documents Certifying that the Manufacturer is Authorized to Manufacture Investigational Medicinal Products or Comparators for Export by the Appropriate Authorities in the Country of Export

Regulatory Requirements for Marketing Authorization, GMP Standards Applicable and Any Official Verification of GMP Compliance

All Other Factors of Which the QP is Aware that are Relevant to the Quality of the Batch

Physical Examination of Packaging

Factors of Which the QP is Aware that are Relevant to the Quality of the Batch
Factors of Which the QP is Aware that are Relevant to the Quality of the Batch
Factors of Which the QP is Aware that are Relevant to the Quality of the Batch
Factors of Which the QP is Aware that are Relevant to the Quality of the Batch

Global Capabilities – Quality Foundation & Services

Bilcare GCS Quality Services

Bilcare GCS Europe can be utilized to support QP Services for both Americas and Asia facilities.

GLOBALCAPABILITIES GLOBALCAPABILITIES

AMERICAS AMERICAS

EUROPE EUROPE

ASIA ASIA

QP QP Services Services

1

1

1

1

- Fully Supported 1 - Achieved with Support from Bilcare GCS Europe

QP QP Services Services 1 1 1 1 - Fully Supported 1 - Achieved with Support
QP QP Services Services 1 1 1 1 - Fully Supported 1 - Achieved with Support
QP QP Services Services 1 1 1 1 - Fully Supported 1 - Achieved with Support
QP QP Services Services 1 1 1 1 - Fully Supported 1 - Achieved with Support

Assuring Success: The Next Steps

Assuring Success: The Next Steps Your Strategic Alliance With Us Bilcare GCS will facilitate your speed

Your Strategic Alliance With Us

Bilcare GCS will facilitate your speed to market through utilization of vendor capacity, flexibility and expertise; ultimately reducing fixed cost thereby strengthening your worldwide competitiveness.

The Next Steps

Alliance Objective

Alliance Leadership

Integration Process

Realistic Potential

Commitment on Technology

Effective Governance Structure

Communications Plan

Timeframe for Action

Internal and External Cross Functional Collaborations

Structure • Communications Plan • Timeframe for Action • Internal and External Cross Functional Collaborations
We Look Forward to Meeting Your Needs!
We Look Forward to Meeting Your Needs!

We Look Forward to Meeting Your Needs!