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REGULATORY AFFAIRS
New drugs, medical devices, and biologics require U.S. Food and Drug Administration approval. The regulatory environment in which we operate
protects the consumer by using a thorough and rigorous method for evaluation, testing, review, and approval of new medical products.BCF's team has prepared for regulatory submission the complete range of regulatory documentation in a wide range of therapeutic and product categories.
BCF is proud of its record of providing outstanding professional regulatory service to our clients – both large and small. Following are the services we provide:
- Regulatory Risk Assessment for New Drugs, Devices, and Biologics
- Document Development (IND, NDA, ANDA, PLA, ELA, PMA, IDE)
- Regulatory Compliance Audits and Guidance (GLP, GCP, GMP)
- Study Master File Setup and Training
- Adverse Event Tracking and Reporting