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Biologics Consulting Group, Inc.
Biologics Consulting Group, Inc. (BCG) is a team of consultants
who provide national and international regulatory and product development
advice on the development and commercial production of biological,
drug and device products. Our staff consists of experts in regulatory
affairs, product manufacturing and testing, pharmacology/toxicology,
facility inspections, statistics, program management, and clinical
trial design and evaluation. Many of our consultants are former
CBER, CDER, and CDRH reviewers, certified FDA inspectors, and senior
scientists from the biotechnology industry. BCG
was founded on the realization that the regulatory process for biological
products differs significantly from that for drugs and medical devices,
and requires specific expertise based on the unique biochemical
nature of the products. While the FDA and ICH regulatory guidance
documents provide a necessary framework for biotechnology product
development strategies, practical regulatory and operations experience
is a vital part of successful licensure and post-market support.
Today, Biologics Consulting Group, Inc. specializes not only in the preparation and review of CBER regulatory applications (INDs and BLAs) as well as the inspection/audit of biologics manufacturing facilities but also in similar regulatory activities for drugs, device and combination products. Because of our familiarity with FDA expectations we have an excellent reputation at the Agency for filing high-quality, easily reviewable applications. Click here to view full list of biologics consulting services. Page Updated: 22 January, 2008 |
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