Latest News & Updates

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

EMA Announces Brexit Business Continuity Plan

In a press release issued on August 1, 2017, The European Medicines Agency (EMA) announced that it “has developed and initiated a business continuity plan to deal with the uncertainty and workload implications linked to the United Kingdom's (UK's) withdrawal from the European Union (EU) and the Agency's...

Thursday, August 3, 2017 | Read More

EU Countries Contend to Be New Host Country of the European Medicines Agency

Sentry BioPharma Services provides drug product management, global drug distribution, GMP storage and specialized services like pharmaceutical labeling, packaging and kitting.  Sentry plays a critical role in protecting temperature-sensitive product safety, identity, strength, purity and quality (SISPQ)...

Monday, July 31, 2017 | 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