Download the Flash player at www.macromedia.com.

 

MISSION STATEMENT

Providing scientific and regulatory consultant services

to the global pharmaceutical,

dietary supplements and medical devices

and diagnostic products industries

IRA R. BERRY

90 Wild Dunes Way

Jackson, New Jersey 08527

(732) 833-1666  (Office)

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, project management. Technical expertise in pharmaceuticals, nutritional supplements, dosage forms and APIs, 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

• Personnel training for domestic and foreign plant audits for CGMP

•  API and dosage form activities

•  Preparing and filing DMFs and ANDAs for efficient product approvals

•  Facility and documentation CGMP upgrade programs, eg, SOPs and Quality Manuals

•  Create and lead teams for regulatory compliance and expedited product approvals

•  Facilitate global regulatory relationships

o   March 2003 speaker in Hangzhou, China on preparation of DMFs

o   In 2004 and 2009 invited by Chinese sFDA to  present two day workshops on CGMP

o   December 2010 session moderator in PQRI-FDA workshop, on process drift in manufacture of APIs

o   Worked with a Chinese manufacturer to resolve four FDA Warning Letters

• Establish joint ventures with marketing partners

• Manage projects for new product development

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

                          Senior Vice President, Quality

• Corporate responsibility for Quality Assurance and Quality Control

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

                          Executive Vice President

• Responsible to coordinate global regulatory affairs, compliance and quality assurance operations for 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

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

• 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)

                              (Chairman 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 (PQRI), 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

                                     Received FDA Commissioner's Special Citation

                        (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, 2008)

                        Chapters in the Encyclopedia of Pharmaceutical Technology – GMP and
                        Technology Transfer (2002, revised edition in process)

                        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 

2275 West County Line Road, Suite 6 #324, Jackson, New Jersey 08527
Phone:732-833-1666    Fax:732-833-4833   E-mail: ira.berry@irb-c.com
Copyright © 2008 International Regulatory Business Consultants, L.L.C.