THART Pharmaceuticals

Email Address: THARTmedicine@gmail.com

Website Address : thartpharma.weebly.com
Phone Number 201-790-9090
Name of Owners: Clark Thomas Jr, Sang Huynh, Youssef Tanzakkine, Bismark Appiah,
Liselot Rosado.
I. Abstract
THART Pharmaceuticals Company is a big supply pharmaceutical company. Our plan is
to make the best product of relief medicine such as like Tylenol, Aspirin. Our goal is to help
people from alleviate suffering of sickness, and to save lives for patients. We also have plan to
build some types of medical professional because most our medical. Furthermore, we only sell
medicine to hospitals and pharmacy, and medical professionals.
Moreover, our independent medical supply try to find success in the United States and
also expand to around the world. We have two supplies warehouse, a big one is on Jersey City,
and the other one is on Newark City. Our company would like to work in the healthcare industry,
so we provide all medicine and equipment to relieve sickness to patient, and also try to help
doctors. We also have many professionals who are master in developing medicine. Our
company goal is to achieve something meaningful and important for patients, for healthcare and
for ourselves. Our success depends on the combined contributions of talent, dedicated and
impassioned people. Moreover, our company has lasting impact on the wellbeing of patients and
healthcare system. Hence, THART Pharmaceuticals Company invites you to explore our
medicine company because our success truly depends on our contributions to shared goal and the
combined intelligence and skill to make best relief medicine for patients.
We have created many marketing strategy and sale strategy through survey and study to
understand what target for customers. Moreover, our company is focused on quality of products
and cost competitiveness with other companies. In addition, we also have created new policies
and procedures manual, as well as there are many team members who have their responsibility to
do their jobs on projects.
We are investing many millions dollar to develop new products and also to pay for many
our health professions, supplies and materials to keep company moving forward. More than 100
employees have worked in our industry, the majority is professional in medicine. Moreover, our
company has created an website which is thartpharma.weebly.com that contains our information
about medicines and instrument that support for our professional healthcare.
II. Sales Forecast
One thing is assured when it comes to generic pharmaceutical manufacturing company, if
your products are well – packaged and branded and if your production plant is centrally
positioned and easily accessible, you will always attract customers cum sales and that will sure
translate to increase in revenue generation for the business.

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 We are well positioned to take on the available market in Newark – New Jersey and
every city where our generic pharmaceutical products will be sold, and we are quite optimistic
that we will meet our set target of generating enough income / profits from the first six month of
operations and grow the business and our clientele base.
We have been able to critically examine the generic pharmaceutical manufacturing
industry and we have analyzed our chances in the industry and we have been able to come up
with the following sales forecast. The sales projections are based on information gathered on the
field and some assumptions that are peculiar to similar startups in Newark – New Jersey.
Below is the sales projection for THART Pharmaceuticals, LLC, it is based on the
location of our business and other factors as it relates to small scale and medium scale generic
pharmaceutical manufacturing company start – ups in the United States;
● Marketing Strategy and Sales Strategy
Before choosing a location for THART Pharmaceuticals, LLC and the kind of generic
pharmaceutical products we will produce, we conduct a thorough market survey and feasibility
studies for us to be able to penetrate the available market in our target market locations.
We have detailed information and data that we were able to utilize to structure our
business to attract the numbers of customers we want to attract per time and for our products to
favorable compete with other leading generic pharmaceutical manufacturing brands in the United
States of America.
We hired experts who have good understanding of the generic pharmaceutical
manufacturing industry to help us develop marketing strategies that will help us achieve our
business goal of winning a larger percentage of the available market in Newark – New Jersey
and other cities in the United States of America.

In other to continue to be in business and grow, we must continue to sell our generic
pharmaceutical products to the available market which is why we will go all out to empower or
sales and marketing team to deliver our corporate sales goals.
In summary, THART Pharmaceuticals, LLC will adopt the following sales and marketing
approach to sell our generic pharmaceutical products;
● Introduce our generic pharmaceutical products brand by sending introductory letters to
pharmacy stores, hospitals, residence, pharmaceutical merchants, retailers and other
stakeholders in Newark – New Jersey and other cities both in the United States of
America.
● Open our generic pharmaceutical manufacturing company with a party to capture the
attention of residence who are our first targets
● Engage in road show in targeted communities from time to time to sell our products
● Advertise our products in community-based newspapers, local TV and radio stations
● List our business and products on yellow pages ads (local directories)
● Leverage on the internet to promote our generic pharmaceutical product brands
● Engage in direct marketing and sales

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 ● Encourage the use of word of mouth marketing (referrals)

Organizational Matters

1. Business Ownership:

Our company consist of individuals who perform the same function, such as engineering
or manufacturing, or have the same expertise or skills, such as graphics design or mechanical
assembly. Each functional group, or component, concentrates on performing its own activities in
support of the company’s business mission. The focus is on the technical excellence and cost
competitiveness of the company’s products, as well as the importance of the contribution of each
functional component’s expertise to the company’s products.
Also, the company periodically form project teams to work on internal company projects,
such as developing new products, implementing a new information system, redesigning the
office floor plan, improving manufacturing processes, implementing an energy reduction project,
or updating the company policy and procedures manual. For such projects, a multifunctional
project team is formed, with members selected by company management from the appropriate
sub functions in marketing, engineering, manufacturing, and procurement. Team members may
be assigned to the project either full time or part time, for a part of the project, or for the entire
project duration. In most cases, however, individuals continue to perform their regular functional
jobs while they serve part time on the project team. One of the team members, or possibly one of
the functional managers or vice presidents, is designated as the project leader or manager.
The project manager does not have complete authority over the project team, because
administratively the members still work for their respective functional managers. The project
manager may have project authority, but the functional manager retains administrative and
technical authority over the people who are assigned to the team. Because team members view
their contribution to the project in terms of their technical or slowing down the project effort. On
the other hand, if the company president gives the project manager the authority to make
decisions when there is disagreement among team members, decisions might reflect the interests
of the project manager’s own functional component rather than the best interests of the overall
project. For example, take a situation in which there is disagreement about the design of a new
product, and the project manager, who is from the engineering function, makes a decision that
refunctional expertise, their allegiance remains to their functional managers. If there is conflict
among the team members, it usually works its way through the organization hierarchy to be
resolved, duces the engineering design cost of the product but increases the manufacturing cost.
In reporting project progress to the company president, the project manager then makes some
biased comments regarding the viewpoints of team members from other functional components,
such as “If manufacturing were more willing to consider other production methods, they could
make the product for a lower cost. Engineering has already reduced its design costs.” Such a
situation would require the company president to get drawn into handling the conflict.

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 If the project manager does not have full authority for project decisions, then he or she
must rely on leadership and persuasion skills to build consensus, handle conflict, and unify the
team members to accomplish the project objective. The project manager also needs to take the
time to update the other functional managers in the company regularly on the status of the project
and thank them for the support of their people assigned to the project. There may be situations in
which a team is assigned to work on a project that is strictly within one particular functional
component. For example, the manager of technical documentation may form a project team of
editors and documentation specialists to develop common standards for all technical documents.
In such a case, the particular functional manager has full authority over the project, and conflict
can be handled more quickly than when it arises within a multifunctional project team

2. Management:

Each member is responsible for overseeing every aspect of the business It works on
multiple projects at any one time, at various stages of completion. As projects wind down and are
completed, the company hopes to get contracts for new projects. People are hired to work on a
specific project; they may be reassigned from a project just completed if they have the
appropriate expertise. Each project team is dedicated to only one project. When their project is
completed, unless team members are assigned to another project, they might be laid off. To
accomplished this goal, we divided the management level on 7 sections.
A. Finance
Money is the fuel that keeps company running. to understand how it's flowing in and out of our
company. Small business finance tasks include:
· Obtain and manage working capital
· Compile and read financial reports
· Strategize and troubleshoot based on the information in your financial reports.

B. Bookkeeping

to must keep records of its day-to-day financial workings. This information provides the
foundation we draw on to manage our company's finances. we also use this information when
paying employees, applying for loans and filling out tax forms.
· Enter and organize purchasing information in a ledger or database
· Enter and organize information about revenue in a ledger or database
· Track accounts payable and accounts receivable
· Write paychecks and manage payroll information

C. Human Resources

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our employees are important company assets. Having employees creates a list of human
resources responsibilities.
· Hire and train personnel
· Maintain records of employee work history and tax information
· Administer employee benefits
· Address employee issues and complaints
· Take disciplinary action in case of poor employee performance

D. Purchasing

The company needs supplies and materials to keep things running. Your purchasing department
makes sure we have what we need when we need it.
· Keep inventory records tracking what you have on hand
· Order supplies and materials as needed
· Organize stock, so you know when to reorder

E. Production

Since the company is a pharmaceutical company, we need to oversee the process of creating that
product from start to finish.
· Receive orders and set production numbers
· Monitor and improve workflow
· Maintain and repair equipment
· Package and store finished product

F. Customer Service

Our customers keep you in business, so you need to stay in touch with them and understand their
needs.
· Work with customers through each phase of your sales process
· Receive and respond to customer feedback
· Take care of customer needs and special requests

G. Marketing

marketing tasks are geared toward creating demand for our products and managing the image
that the projects.
· Create a marketing budget
· Manage company branding
· Oversee advertising copy and venues

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· Align each aspect of your company's operations to create an image that reinforces your
brand.

3. Personal:

Strength/Weakness
As a department manager, I must identify employee strengths by comparing performance
standards to the manner in which employees perform their job duties and tasks. Performance
appraisal-worthy strengths include job skills, capabilities and characteristics. Identifying
strengths is just the beginning, though. When I identify employee strengths, employees learn
about the areas where they excel and more about the areas where they can improve performance.

1. Skills and Proficiencies

Job proficiency is clearly an important strength worth mentioning in a performance appraisal.
Employees with excellent job skills or proficiency demonstrate their expertise in performing the
functional aspects of their jobs. An administrative assistant, for example, must be proficient with
office programs and software applications to provide support to managers and directors. An
example of a registered nurse’s proficiencies is mastery of clinical procedures.

2. Ethics and Integrity

Personal characteristics such as work ethic, business ethics and integrity are strengths measured
within a performance appraisal. Although quantitative measurement of personal characteristics is
difficult, the actual measurement comes from peer evaluations and customer feedback.
Employees who demonstrate high levels of integrity usually find it easy to gain others’ trust --
whether they are co-workers or external contacts such as clients, customers or colleagues outside
the workplace.

3. Job Knowledge
Job knowledge is a different measurement from job skills. Job knowledge demands
understanding practices related to overall performance and how and when to apply certain
practices, rules or regulations. A human resources manager exhibits strength in the area of job
knowledge by embracing appropriate human resources best practices, understanding employment
trends and applying labor and employment law to work situations. Job knowledge requires that
an employee keep abreast of news that affects his profession and his career, which shows an
effort in building his reputation as well as contributions to his employer.

4. Conscientiousness
Conscientious employees care about work quality and customer satisfaction. They demonstrate
this through ensuring each step they take during assigned projects is done the proper way and

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will produce the best outcome. For instance, a sales employee follows up with calls to clients
after each sale to determine if the customer is satisfied with the product or service.

5. Commitment
There are several ways an employee can demonstrate commitment. Two popular ways include
sticking with the company during lean times and building a long record of success while with the
company. Companies in the growth stages of development depend heavily on employees who are
committed to the organization. In fact, the company’s growth depends on employees capable of
visualizing its success and using their talents to help achieve their own professional successes as
well as the company’s goals.

Financial Plan

Investing in THART starts at a minimum of $1,000,000 which will be divided into research and
marketing, office leasing, salaries and benefits for employees, insurance, construction of a
generic pharmaceutical plant, and miscellaneous costs. How we market is crucial to our initial
success and will ultimately determine our future.

To start financing our company, we will use personal funds initially. The next step is to reach out
to “friends and family” who support our mission and believe in our product. We will
progressively reach out further in the community and surrounding area asking for any donations.
It is very important for the company to be very clear on what we are selling and why they should
invest in it. Another step we will take is seeking public private grants that are available from the
Defense Advanced Research Projects Agency and other organizations. These programs can help
fund a company ranging anywhere from $100,000 to $1 million.

Since we consider ourselves to be a small business, we will mainly reach out to banks like Wells
Fargo and apply for SBA loan 7(a), which provides a maximum of $5 million for small business
startups.

Inevitably, we will need to reach out to investors. The only way to successfully convince
investors is by proving what we do is different and better and will work. The pharmaceuticals
industry is massive and there are already so many other competitors in the area and worldwide.
THART mission is to create generic pharmaceutical products available to the public and to
private corporations.

Legal Approval (Sang)

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1. Legal document to sale drugs
FDA’s Center for Drug Evaluation and Research (CDER) performs an essential public's
health task to make sure that safe and effective drugs to patients. Moreover, FDA’s Center for
Drug Evaluation and Research also does to evaluate pharmaceutical companies which must first
do extensive testing and document the results. The drugs must be sent to CDER( Center for Drug
Evaluation and Research), who assigns team of doctors, chemists, pharmacologist to review the
drugs. Normally, most drugs take around 6 to 10 years to get decision before getting into
markets.
A. Phase of drug development
· Discovery and development
- Discovery involves researchers finding new possibilities for medication through testing
molecular compound such as either notice about unexpected effects from existing treatments, or
what benefits to patients.
· Preclinical Research
- Since researchers have examined the possibilities a new drug may contain to determine its
potential for harm. There are two types in this categories of preclinical research: vitro and vivo.
In vitro refers to experiments with a controlled environment outside of a living organism. On the
other hand, the experiments of vivo occur in a living organism. Both these two types of
categories must follow regulated laboratory practices.
· Clinical Research
- After identifying the drugs is safe, researcher must examine how drugs interact with human
body.
· FDA review
- When the pharmaceutical company can prove that a drug is safe and is affected in treating
condition. The company can file an application to allow marketing of the drug. Clinical result,
label information, safety information, drug abuse potential, patient information and direction for
use are required for application process before drugs get into the markets.
- Normally, most drugs take around 6 to 10 years to get decision before getting into markets.
Researchers must be identify what quality of products or any issues to solves before approval.
· FDA post market safety Monitoring
- Even after the drugs is on the market, sometimes there are some issues that may arise. If a
company wants to change anything about the drug formulation or approve it for new ones. The
company must applied with FDA, because FDA always make sure pharmaceutical companies
follow regulations.
- Moreover, new drugs are protected by patents when they approve for marketing.
B, Time for to get into market
The FDA approval process can be long and tenuous, especially for patients waiting on
new drugs to get in markets. However, the FDA has developed four methods to speed up the
approval process: fast track, breakthrough therapy, accelerated approval, and priority review.

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- Fast track is a process to speed up development and expedite the review of drugs that treat
serious conditions.
- Breakthrough therapy is a process to speed up development and expedite the review of drugs
that treat normal conditions.
- Accelerated approval is a process for drugs that fill an unmet medical need and have evidence
of potential clinical benefit.
- Priority review is a drug application within six months.
2. General provision and registration
A, registration fee
Governments regulate goods and services whenever there is a market failure. For
pharmaceutical, there is an imbalance of information between the producers and consumers.
Normally, pharmaceuticals have a major impact on public health. Thus, government should
regulate pharmaceuticals in order to enhance public welfare. Drug regulatory authority(DRA) is
absolutely for dealing with pharmaceuticals.
Drug regulatory authority(DRA) registration fee may also be used as a policy instrument.
Drug regulatory authority(DRA) can be used to increase Drug regulatory authority(DRA) human
and material resource to speed up regulatory approval. However, many countries charge
differentially with regard to generic drugs.
Pharmaceutical companies intending to register a product should accept the idea of
paying registration fee for cost recovery provided that there is “Value”.

The Prescription Drug User Fee Act (PDUFA) was created by Congress in 1992 and
it authorizes FDA to collect fees from companies which produce certain human drugs and
biological drugs.
A, what are application fees?
Each company submits a human drug application is assessed an application fee as follow:
- A human drug application for which clinical data with respect to safety or effectiveness are
required for approval is assessed a full application fee
- Human drug application fees are due when the application is submitted

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B, Is there a reduction of fees for human drug applications that are refused for filling or
are withdraw before or after filling?
Yes.
- 75 percent of the application fee is refunded for any application that is refused for filling or is
withdraw before filling.
- If an application is withdraw after it is filled, FDA may refund the fee if no substantial work
was performed on the application.
C, What is the timeframe for requesting a reduction or refund of fees?
- A form FDA 3971 must be submitted no later than 180 days after such fee is due
D, Where should a company send its request?
For US Mail:
Prescription Drug User Fee Food and Drug Administration
10001 New Hampshire Avenue, Room 2185
Silver Spring, MD 20993-0002

For Courier Delivery

Prescription Drug User Fee Food and Drug Administration
10001 New Hampshire Avenue, Room 2185
Silver Spring, MD 20903

2. Federal and state drugs selling laws

A, patents
Company may apply for a patent of the drug, or the process of producing the drug. The grating
exclusivity rights are typically about 20 years. Patent is the part to consider for the company to
recover the costs of research and development through high profit margins for the branded drugs.
As the patent protection are expired, a generic drug us developed and sold by a competitive
company. Moreover, the generic product is often selling at low price due to less expensive of the
development and approval of generic.
B, Security Requirement
· All applicant and registrants shall provide effective controls and procedures to guard to
against theft and diversion of control substance.
· Material and construction will provide a structural equivalent to the physical security control

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· Division also need for strict compliance with security requirement:
o The type of activity conducted ( preparing dosage form, packing , labeling)
o The typing of building construction comprising the facility
o The adequacy of key control system and combination lick control system
o The procedures for handling business guest, visitor, maintenance personal
o The available of local police protection or applicant’s security personnel
C, Physical Security Controls for Non Practitioners: Storage Area
· Practical schedule II and III medication in solid dosage form should be stored in a safe or
substance steel cabinet that is locked at all time. They are required for refrigerated should be kept
in a lock refrigerator.
· The safe steel cabinet should comply with the state and federal requirements for storage of
small quantity of medications.
D, Label means any display of written, printed or graphic matter placed upon the commercial
container of any controlled substance. Reading the product label is the most significant part of
taking care of ourselves when using medicine. Over the counter medicines is normally without a
prescriptions of doctors.
What is on label
· Active gradient: amount of active gradient per unit
· Uses: symptoms or disease product will treat
· Warning: possible interactions or side effects
· Inactive: substance such as color or flavors
· Directions: how much pills to take , how many time per day
· The expiration date: when applicable
· Lot or batch code
· What to do if overdose

References

://diabetespac.org/fda-drug-approval-process/

https://www.njconsumeraffairs.gov/regulations/Chapter-45H-Controlled-Dangerous-
Substances.pdf
https://www.njconsumeraffairs.gov/regulations/Chapter-45A-Subchapter-27-Uniform-
Prescription-Blanks.pdf

https://www.njconsumeraffairs.gov/regulations/Ch-45A-Subch-35-Prescription-Monitoring-
Program.pdf

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