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MISSION STATEMENT
Providing scientific and regulatory
consultant services
to the global pharmaceutical,
dietary and medical devices
and diagnostic products industries
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Industry Accomplishments
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Previously NAPM Board of
Directors, Executive Committee, Technical
Committee Chairman, Bulk Committee Co-chairman - now GPhA
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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 |
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Generic industry representative
to FDA PQRI, Drug Substance Technical Committee |
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Gelatin Capsule Working Group
with CMC Coordinating Committee of FDA |
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Industry Development and Training
Committees with FDA for SUPAC-IR and BACPAC Guidances |
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USP Advisory Panel on Analytical
Methods for Non-prescription Drugs and Nutritional Supplements |
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(Gelatin) BSE Task Force with FDA |
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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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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. |
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