---
title: "Landing in Europe: Techdow's EU Market Entry"
description: "Discover how QbD Group helped Techdow Pharmaceutical, a leading global pharmaceutical company supplying complex biologicals, achieve EU GMP certification, Marketing Authorisation, and full commercialisation across Europe."
url: https://qbdgroup.com/en/case-studies/techdow-eu-market-entry
type: "Case study"
language: en
published: 2026-07-22
publisher: "QbD Group"
citation: "QbD Group, \"Landing in Europe: Techdow's EU Market Entry\", https://qbdgroup.com/en/case-studies/techdow-eu-market-entry"
---
# Landing in Europe: Techdow's EU Market Entry
> Discover how QbD Group helped Techdow Pharmaceutical, a leading global pharmaceutical company supplying complex biologicals, achieve EU GMP certification, Marketing Authorisation, and full commercialisation across Europe.

[Techdow Pharmaceutical](https://www.techdow.com/en/) 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
---
Source: https://qbdgroup.com/en/case-studies/techdow-eu-market-entry — © QbD Group. Quote freely with attribution and a link back.