Regulatory
Pharmaceutical Regulatory Compliance and Collaboration
Sentry 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 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.
If you face regulatory concerns or uncertainties, discuss them with Sentry,
Regulatory Authorities
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. 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 (EMEA), Europe
Health Canada (HC), Canada
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Irish Medicines Board (IMB), Ireland
World Health Organization (WHO), International
International Pharmaceutical Excipients Council (IPEC), International
United Nations Office on Drugs and Crime (UNODC), International
Department of Health and Aging, Therapeutic Goods Administration (TGA), Australia
Federal Institute for Drugs and Medical Devices, Germany