We’re pleased to announce that in January 2019 a regular inspection of Good Manufacturing Practice was conducted by the State Institute for Drug Control in Prague. On the basis of their findings a GMP Certificate will be issued to the full extent of our authorization to manufacture medicinal products. The inspection report will also be provided to the US FDA under the MRA agreement (mutual recognition of GMP inspection results) between the US and EU. Quinta-Analytica is one of the first companies whose inspection report has been requested by the US FDA from the State Institute for Drug Control, and we’re honored to receive this recognition.”

Additional News

  • 17 December 2025

    PF 2026: Thank You from Quinta-Analytica

    In 2025, Quinta-Analytica continued to turn complex development challenges into tangible progress. Our PF 2026 message looks back at key milestones and thanks the partners, clients, and teams who made them possible.

  • 15 December 2025

    IVBE for locally acting drugs: insights from Conscio Science Day in Munich

    Can bioequivalence for locally acting drugs be demonstrated without a single subject in a clinical trial? Yes, if your in vitro bioequivalence (IVBE) toolkit is set up in the right way.

  • 20 November 2025

    Webinar: Streamlined Evidence Strategies for Biosimilars: Analytics, PK and Immunogenicity in focus

    On behalf of Conscio Group, we are pleased to invite you to the upcoming free educational webinar from biosimilar series.