Biotech Research Group

BRG has helped many medical device companies with their 510k Class I, 510k Class II, 510k Class III and De Novo submissions. Email us for an immediate proposal. In addition, we can help with your quality management system and device development.

BRG prepares facilities for FDA inspections. BRG can audit facilities ranging in the smallest size to 100,000 square feet facilities. BRG will perform gap assessments relating to FDA Code of Federal Regulations and Current Good Manufacturing Practices (cGMP), Current Good Laboratory Practices (cGLP), Current Good Clinical Practices (cGCP) and Current Good Tissue Practices (cGTP). BRG customizes the FDA mock audit to the needs of our clients.