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Biologics Consulting Group, Inc. (BCG) is an international consulting firm whose consultants 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. Because of our familiarity with FDA expectations we have an excellent reputation at the Agency for filing high-quality, easily reviewable applications.