Latest News & Updates

Biologics Contribute to Growth in Pharma Products Cold-Chain Market

In its September issue, Pharmaceutical Commerce details the previous and expected contributions of biologic products to its forecast of cold-chain market growth predicting sales of cold-chain drugs and biologics will outpace overall industry growth through 2022. It is reported that “as of 2018, global...

Wednesday, September 12, 2018 | Read More

FDA Researchers Explore Fundamental Chemical Reaction that Could Threaten the Quality of Therapeutic Protein Products

In a recent news release the FDA described research it has conducted regarding detection of protein carbonylation, an oxidative reaction that may occur in therapeutic protein drug products during manufacture, storage, use, and transport potentially causing structural alterations and threatening stability,...

Tuesday, September 11, 2018 | Read More

Sentry representatives attend DCAT week

Sentry BioPharma Services is pleased to announce delegates from Sentry’s Business Development team will be in New York City attending the Drug, Chemical & Associated Technologies Association (DCAT) Week March 19th -22nd. The four-day conference brings together key sourcing, procurement and business...

Monday, March 19, 2018 | Read More

Regulatory

Pharmaceutical Regulatory Compliance & Collaboration

Sentry BioPharma Services (SBPS) 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.

For more information about how Sentry can address your confidential regulatory concerns or uncertainties, contact Sentry via email or by phone at 1-866-757-7400.

Regulatory Authorities & International Organizations

Pharmaceutical Regulatory Compliance Assurance

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