What We Deliver

Fisher BioServices maintains a global, comprehensive, and integrated Quality System based on regulatory requirements and industry best practices. Customer satisfaction, efficient processes, and regulatory compliance are integral parts of our commitment to quality.

Regulatory Compliance

Our quality policies and standard operating procedures (SOPs) are implemented across our facilities, ensuring uniformity and adherence to customer and regulatory requirements. Our Quality System follows current Good Manufacturing Practices (cGMP) guidelines and complies with governing bodies.

  • US cGMP - Food and Drug Administration (FDA)
    • 21 CFR 210, 211, 1271
    • 21 CFR part 11 and part 58 (where applicable)
  • US Drug Enforcement Agency (DEA)
  • State pharmacy regulations
  • Transportation Security Administration (TSA) Certification at 3 sites
  • International Air Transport Association (IATA)
  • Department of Transportation (DOT)
  • Centers for Disease Control and Prevention (CDC) for A, B, and C priority pathogens
  • ISO 9001:2015 certification (UK site)
  • Parenteral Drug Association (PDA) guidelines for cold chain shipping
  • In-house Qualified Person (QP) release at our United Kingdom facility

Audit

Our facilities around the world are regularly audited by regulatory authorities such as the US Food and Drug Administration (FDA), the UK Medicines and Healthcare Products Regulatory Agency (MHRA), the European Medical Authority (EMA), and the Swissmedic for CH. Additionally, we host 70+ customer audits annually and maintain a comprehensive internal audit system to ensure compliance in all our operations.

For additional information regarding our current regulatory history and current registrations for both our US and UK facilities please contact us.

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