Latest News & Updates

Resilience Analysis of Vaccine Supply Chain

Released by Sentry BioPharma Services In, as it says, what now appears to be a prescient discussion described in an article written in April, 2020[1], Tim Gunn wrote about how vaccine cold chain supply practices were soon going to be put to the test to store and distribute COVID-19 vaccines....

Friday, July 23, 2021 | Read More

Mitigating the Logistical Challenges Associated with Clinical Studies of Investigational Drugs

How Sentry BioPharma Services supports clinical studies with just-in-time custom labeling/kitting/packaging and more. Released by Sentry BioPharma Services Contract Pharma Staff 06.17.21As crucial to innovation as they are, clinical studies come with a unique set of logistical challenges...

Thursday, June 24, 2021 | Read More

The Benefits of Outsourcing Cold Storage

How full range of storage environments and services of Sentry BioPharma Services, Inc. (Sentry) save time and money for pharma companies. Released by  Sentry BioPharma Services •Contract Pharma Staff• 03.31.21A significant recent trend in the biopharma industry has been an increasing number of...

Monday, May 17, 2021 | 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

Regulatory Compliance

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