Anthony Celeste

ANTHONY CELESTE

PROFESSIONAL EXPERIENCE

Aug 2004 - Kendle International Rockville, MD

Senior Vice President
As Senior Vice President, Mr. Celeste participates in the day
to day management of the company. Primary responsibilities
include providing day to day regulatory and compliance advice
to Kendle clients on a variety of FDA issues. Meet with
potential clients to discuss Kendle services and to market
Oct 1986 - Aug AAC Consulting Group, Inc.
President and CEO
As President of AAC Consulting Group, Inc. (now a subsidiary
of Kendle International), Mr. Celeste supervises consulting
activities covering the full range of FDA regulated products
and practices. He provides advice and assistance on general
FDA matters including FDA philosophy and policy, strategic
planning for regulatory compliance, interpretation and
explanation of GMPs, enforcement, and procedural issues
Jul 1976 - Oct Food and Drug Administration, Wash. DC
Director, Office of Regional Operations
Provided overall direction, support, supervision, and
coordination for FDA’s field offices nationwide. Appointed the
Director of the Office of Regional Operations in 1985. Had
final authority responsible for field office activities.
Jun 1973 - Jul Food and Drug Administration, Cincinnati, OH
District Director
Accountable for all the district’s day-to-day and long-range
management. District operated a microbiological laboratory for
all Region V FDA. Provided a full range of analytical and
investigation service.
Dec 1970 - Jun Food and Drug administration, Boston, MA
Deputy Regional Food and Drug Director
Responsible for day to day management of the district office.
Scheduling of project work, case review, managing laboratory,
inspection and compliance activities, etc.
May 1969 - Dec Food and Drug Administration, Detroit, MI
Laboratory Director
Responsibilities included day-to-day activities of the district’s
laboratory branch. Directed a staff of 35 analytical chemists,
microbiologists and associated support personnel.
Responsibilities included budgeting, planning, hiring and
Jun 1968 - Oct Food and Drug administration, Wash. DC
Food and Drug Officer
Responsible for food and drug regulatory case review and
development of Agency-wide compliance policy.

CONFIDENTIAL Last Updated:

Jun/08/2009 Page 1 of 2
 Anthony Celeste

Jan 1966 - Jun Food and Drug Administration, Kansas City

Supervisory Chemist
Accountable for 12 – 16 analytical chemists analyzing the full
range of products regulated by the Food and Drug
Administration. Responsibilities included analytical work to
support the district’s illegal undercover drug activities.
Jul 1960 - Jan Food and Drug Administration, New York
Chemist
Analytical chemist concentrating in pesticide residue and drug
product analysis.

EDUCATION

1960 Fordham University - United States

Bachelor - Chemistry

PROFESSIONAL AFFILIATIONS
Food and Drug Law Institute - Member
● Member since: Jan 2007
Regulatory Affairs Professional Society - Member
● Member since: Jan 2007
International Society of Pharmaceutical Engineers - Member
● Member since: Jan 2007
Food and Drug Alumni Association - President
● Member since: Apr 2007

PUBLICATIONS & PRESENTATIONS

Application of Pharmaceutical CGMPs, D. Barr et al., Food and Drug Law Institute,
1997

“A Rapid Method for the Qualitative Determination of Antihistamines and Some

Related Compounds by Gas Chromatography,” JAOAC, Vol. 49 No. 3 1966

“Separation and Determination of Some Antihistamines by Gas Chromatography,”

JAOAC, Vol. 46 No. 6 1963
“Mercury in Fish,” FDA Papers, 1970

“Implementing a System of Good Manufacturing Practices for Investigational New

Drugs” Food and Drug Cosmetic Law Journal September 1988.

CONFIDENTIAL Last Updated:

Jun/08/2009 Page 2 of 2