REGULATORY
Pharmaceutical Regulatory Compliance & Collaboration
Sentry BioPharma Services ApS (Sentry ApS) operates within a highly regulated industry. Through frequent customer and government agency audits and inspections, Sentry ApS 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 ApS 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 ApS 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.
Regulatory Authorities & International Organizations
- Danish Medicines Agency
- U.S. Food & Drug Administration (FDA), 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
Proven Temperature Sensitive Project Management
For more information about how Sentry ApS’ proven vaccine management system can protect your vaccine throughout the global supply chain, contact Sentry ApS via email or by phone at +45 69 17 71 66.