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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 and medical devices

and diagnostic products industries

 

 

Industry Accomplishments

 

 

bullet Previously NAPM Board of Directors, Executive Committee, Technical 
     Committee Chairman, Bulk Committee Co-chairman - now GPhA

 

bullet Council for Responsible Nutrition - Subcommittee for Industry Standards,  
     developed monographs for nutritional supplements with USP, directed a   
     group to write GMP guidelines for nutritional supplement industry which 
     appear in the current USP and on a committee to write GMP regulations
     with FDA

 

bullet

Generic industry representative to FDA PQRI, Drug Substance Technical Committee

 

bullet

Gelatin Capsule Working Group with CMC Coordinating Committee of FDA

 

bullet

Industry Development and Training Committees with FDA for SUPAC-IR and BACPAC Guidances

 

bullet

USP Advisory Panel on Analytical Methods for Non-prescription Drugs and Nutritional Supplements

 

bullet

(Gelatin) BSE Task Force with FDA

 

bullet

Participated in the past on PMA and PA committees to develop GMP and Product Class Monographs for medical device and diagnostic products, OTC Drug Review

 

 

 

 

 

 

 

 
 

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ira.berry@irb-c.com
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