Latest News & Updates

Understanding the Essential Role of a Qualified Person

Sentry Biopharma's QP can provide batch certification for importation of drug products into the EU as well as audit pharma manufacturing and storage facilities. If you are a company planning to import drug products into the European Union (EU) countries including Austria, Belgium, Bulgaria,...

Thursday, November 17, 2022 | Read More

Sentry Employee, Family, and Friends Event - September 13, 2022

Sentry employees and vendor partners as well as their families and friends shared time together at the Indianapolis Indians game on September 13, 2022.  While the Indians battled the Toledo Mud Hens, the Sentry team enjoyed ballpark hot dogs, brisket, macaroni and cheese, fresh fruit, barbeque,...

Monday, October 3, 2022 | Read More

Sentry Biopharma Services: Protecting Pharmaceutical Integrity

Sentry Biopharma Services protects the integrity of temperature sensitive biopharmaceutical products during the clinical and commercial phases of development. https://youtu.be/wWcVj8SB-Es Sentry Biopharma Services specializes in the storage and global distribution of temperature sensitive biopharmaceutical...

Friday, July 1, 2022 | 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