Pharmaceutical Regulatory Compliance & Collaboration
Sentry BioPharma Services operates within a highly regulated industry. The FDA requires complete compliance with applicable sections of Chapter 21 of the Code of Federal Regulations (CFR). Through frequent customer and government agency audits and inspections, Sentry BioPharma continuously improves its systems and maintains an exemplary compliance record.
Frequently undergoing pharmaceutical audit processes and maintaining open communication channels with local regulatory authorities allows Sentry to develop strategies to fulfill client needs and meet their regulatory requirements. This proactive approach and collaboration allows for rapid implementation of new custom services.
Continuing education and industry involvement by the leadership team enables Sentry and its clients to rapidly acclimate to fast-changing regulatory conditions. Assured government & GMP compliance, in turn, opens opportunity to devote resources to efficiency and additional competitive advantages.
Regulatory Authorities & International Organizations
- U.S. Food & Drug Administration (FDA), United States
- Center for Drug Evaluation and Research (CDER)
- Center for Biologics Evaluation and Research (CBER)
- Center for Devices and Radiological Health (CDRH)
- U.S. Drug Enforcement Administration (DEA), United States
- U.S. Department of Agriculture (USDA), United States
- U.S. Environmental Protection Agency (EPA), United States
- U.S. Customs and Border Protection (CBP), United States
- U.S. Department of Transportation (DOT), United States
- The National Association of Boards of Pharmacy® (NABP®), United States
- Occupational Safety and Health Administration (OSHA), United States
- Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
- European Medicines Agency (EMA), Europe
- Health Canada (HC), Canada
- Pharmaceuticals and Medical Devices Agency (PMDA), Japan
- Health Products Regulatory Authority (HPRA), Ireland – formerly the Irish Medicines Board (IMB)
- World Health Organization (WHO), International
- International Pharmaceutical Excipients Council (IPEC) Federation, International
- United Nations Office on Drugs and Crime (UNODC), International
- Federal Institute for Drugs and Medical Devices (also known as BfArM), Germany