Landing in Europe: Techdow's EU Market Entry

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 Chinese manufacturer with no prior foothold in the EU regulatory landscape.

Beyond the regulatory dossier itself, Techdow's Chinese 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 Chinese 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 Chinese 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 Chinese 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 issued a Letter of Recommendation to SciencePharma, the Polish-based member of QbD Group, reflecting the quality of the partnership and the results delivered throughout this complex, multi-year programme. — Letter of Recommendation — Techdow Pharmaceutical