Curriculum Vitae - International Regulatory Business Consultants

MISSION STATEMENT

Providing scientific and regulatory consultant services

to the global pharmaceutical,

dietary supplements and medical devices

and diagnostic products industries

Ira R. Berry, President

EXPERIENCE Recognized health care manufacturing industry expert, with a blend of technical and business education and expertise in global manufacturing, quality assurance, regulatory affairs, marketing and new business development. Technical expertise in pharmaceuticals, nutritional supplements, dosage forms and bulk, medical devices and diagnostic products and cosmetics, complemented with strong written and verbal communication skills. Commitment to industry demonstrated through organizational contributions as well as numerous presentations, publications and patents.

1/2002–present INTERNATIONAL REGULATORY BUSINESS CONSULTANTS, L.L.C.

President and founder

6/2001-12/2001 DURAMED PHARMACEUTICALS, INC., Somerset, NJ (merged with Barr)

Senior Vice President, Quality

1996-5/2001 WOCKHARDT AMERICAS INC., East Hanover, NJ

Executive Vice President

· Responsible to coordinate global regulatory affairs, compliance and quality assurance operations for worldwide manufacturing operations and product registrations

· U.S. manufacturing and technical operations

· Establishing new manufacturing operations worldwide

· Company liaison with worldwide regulatory agencies

· Oversee the R&D operation to develop a new line of pharmaceutical products for global product registrations

1980-1996 BANNER PHARMACAPS INC., Union, NJ

Corporate Vice President - Technical Affairs 1992-1996

· Responsible to coordinate and establish a Corporate Total Quality Management program throughout the Company's 6 plants worldwide

· Coordinate and develop standard validation programs for all plants

· Provide technical and regulatory assistance to implement the operation of new manufacturing facilities

· Oversee the development of generic drugs to market

· Coordinate a technology transfer program

· Obtained FDA approval for 2 generic drugs in the U.S., one of those being the first generic on the market and increasing Company profits by 100%

· Coordinate regulatory activities throughout the Company

· Create a cohesive management team

· Provide technical assistance to Sales and Marketing

1990-1992 Corporate Vice President - General Manager and Technical Affairs

· Responsible to manage a manufacturing plant as a cost center and also to coordinate and establish a Corporate Quality Standards program throughout the Company

· Reduced the labor headcount by 10% through capital expenditures for upgraded equipment

· Initiated a plan to establish uniform corporate quality standards through all plants

Pharmacaps, Inc., Elizabeth, NJ 1988-1990

Executive Vice President

· Responsible to manage the plant as a cost center, to manufacture
pharmaceuticals, nutritional supplements and cosmetics

· Reporting to me were Production/Operations, Engineering, Quality Control,
Quality Assurance, Regulatory Affairs, Product Development and Technical
Customer Service

· Improved service and delivery to customers while establishing systems to
control inventory and improve production efficiency

· Increased units produced and shipped by 50%

· Improved the Quality Control Laboratory function

Senior Vice President - Technical Affairs 1987-1988

Vice President - Technical Affairs 1982-1987

Director - Technical Services 1980-1982

· Responsible for QC, QA, Regulatory Affairs and Product Development

· Established a state-of-the-art QC Laboratory

· Established a Regulatory Affairs compliance program

· Coordinated and implemented a GMP compliance program

· Established a GMP documentation program

· Developed new customers and new products - OTC, Rx, nutritional
supplements - domestic and international

CARTER - WALLACE, INC., Cranbury, NJ

Plant Manager/Director of Manufacturing

Director of Regulatory Affairs

DENVER CHEMICAL MANUFACTURING CO., Stamford, CT

(acquired by Carter - Wallace)

QA Administrator/Regulatory Affairs Associate

Manager, Chemical Diagnostics Production

PFIZER, INC., New York, NY

Manager, Serum Production

Manager, Product and Process Development

Supervisory Laboratory Technician

EDUCATION

M.B.A. Management - Adelphi University, Garden City, NY

M.A. Biology - Hofstra University, Hempstead, NY

B.S. Biology/Chemistry - Queens College of CUNY, Flushing, NY

PROFESSIONAL AFFILIATION HIGHLIGHTS

National Association of Pharmaceutical Manufacturers (now GPhA)

(Executive Committee)

(Board of Directors)

(Technical and Bulk Committees)

Science Committee

International Generic Pharmaceutical Association

Science Committee

Intellectual Property Committee

Generic Industry Trade Association Representative to FDA Product Quality

Research Institute, Drug Substance Technical Committee

SUPAC-IR Guidance Development Committee (with FDA)

BACPAC Guidance Development Committee (with FDA)

Gelatin Capsule Working Group Member with (FDA) CMC Coordinating Committee

(Gelatin) BSE Task Force with FDA

PUBLICATIONS, PATENTS AND PRESENTATIONS

More than 25 published papers on GMP, validation, softgels and nutritional

supplements

Co-editor of Pharmaceutical Process Validation text (1993)

and Validation of Active Pharmaceutical Ingredients text (2001)

Editor of The Pharmaceutical Regulatory Process text (2004)

Chapters in the Encyclopedia of Pharmaceutical Technology – GMP and
Technology Transfer (2002)

Numerous talks at seminars and radio shows

Patents on antacids, controlled release, chewable gelatin shell and foaming bath
oils

Past faculty member, Fairleigh Dickinson University MBA in Pharmaceutical
Marketing program

[ Home ] [ Who We Are ] [ Curriculum Vitae ] [ Regulatory Services ] [ Compliance Services ] [ Quality Services ] [ Business Services ] [ Industry Accomplishments ] [ Contact Us ]