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INTERNATIONAL REGULATORY BUSINESS CONSULTANTS, L.L.C.

1-732-761-9400

 
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MISSION STATEMENT

Providing scientific and regulatory consultant services

to the global pharmaceutical,

dietary supplements and medical devices

and diagnostic products industries

 

 

Curriculum Vitae

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 

 

 

 

 

 

 

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