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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. The 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 BCG’s 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. BCG’s familiarity with FDA expectations has enabled the company to attain an excellent reputation at the Agency for filing high-quality, easily reviewable applications. www.bcg-usa.com
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