Landing in Europe: Techdow's EU Market Entry

    Techdow Pharmaceutical is a leading global pharmaceutical company supplying enoxaparin sodium APIs and low molecular weight heparin (LMWH) injections, complex biological products. To commercialise their biosimilar in Europe, Techdow required end-to-end support spanning development, GMP compliance, regulatory submissions, and post-authorisation services.

    Challenge

    Enoxaparin is a demanding biosimilar requiring clinical studies for EU registration, placing it among the more complex biological products to bring to the European market. Techdow faced this challenge as a non-EU manufacturer with no prior foothold in the EU regulatory landscape.

    Beyond the regulatory dossier itself, Techdow's non-EU manufacturing facility needed to be aligned with EU GMP standards, a hard prerequisite for any European marketing authorisation. This meant simultaneously managing development activities, clinical evidence generation, manufacturing compliance, and regulatory strategy across multiple years and jurisdictions.

    Approach

    Full-spectrum regulatory and quality support

    QbD Group provided end-to-end support across every stage of Techdow's EU market entry programme, from early development through to post-authorisation services.

    • Development support to meet EU requirements: technology, analytics, non-clinical studies and clinical trials
    • EU GMP standards implementation at the non-EU manufacturing facility
    • Regulatory strategy: dossier compilation, submission and authority liaison
    • EU GMP Inspection Process Management
    • Pharmacovigilance, QC and Qualified Person (QP) services

    QbD Group coordinated this multi-year programme through SciencePharma, its Poland-based member, ensuring consistent oversight and local regulatory expertise throughout the engagement.

    Result

    A complex biosimilar, now commercialised across Europe

    The programme delivered across all critical milestones, taking Techdow from an unfamiliar regulatory landscape to full commercial presence on the European market.

    • EU GMP Certificate obtained: Techdow's non-EU facility certified to EU GMP standards, unlocking market access.
    • Marketing Authorisation approved: granted via National Procedure in Poland and the EU Centralised Procedure.
    • Product commercialised in the EU: Techdow's enoxaparin biosimilar is live and available across the European market.

    Techdow highlighted the quality of the partnership and the results delivered throughout this complex, multi-year programme.

    — Techdow Pharmaceutical