Gain EU and UK market access quickly and confidently  

Europe is an attractive market opportunity for biotech and pharma companies developing innovative drugs. However, obtaining new drug approvals in the UK and EU can be a complex and lengthy process, particularly for advanced therapeutic modalities. 

TMC Commercial provides flexible, comprehensive UK and EU drug commercialisation services for late-stage and commercial-ready biotech and pharma companies — from preparing for submission to post-authorisation — giving you the opportunity to build your own commercial presence without needing to out-license to a partner. 

From regulatory compliance and marketing authorisation applications to pharma distribution and pricing, we can support all aspects of your pharma market access strategy. Our drug commercialisation services reduce the time, cost and other complexities associated with entering new markets, so you can gain marketing authorisation in the EU and UK efficiently and cost-effectively. 

Flexible, comprehensive drug commercialisation services 

Complete support for your pharma commercialisation strategy  

Launch and scale with speed and confidence across the EU and UK. TMC Commercial provides a full-service drug commercialisation solution, including regulatory compliance and marketing authorisation application support, medical affairs, pharmacovigilance, reimbursement and pharma pricing strategy, distribution and quality assurance. 

Keep control of your asset without the operational burden. If your infrastructure is limited, we have the specialist expertise to act as your Marketing Authorisation Holder (MAH), whether as a temporary bridge or a long-term solution. This means you benefit from our operational capabilities while maintaining the strategic flexibility you need to retain control over your products — without the need to out-license. 

Make informed, long-term decisions that maximise patient access. Our flexible approach, deep expertise and commitment to seamless execution accelerate your product's path to market and help you make informed, long-term strategic decisions that maximise impact and patient access. 

The expertise to act as your Marketing Authorisation Holder 

Our drug commercialisation services include acting as your MAH — a role TMC has assumed for many companies over the last 10+ years. As MAH for your product, TMC:

  • Assumes all risks and responsibilities to hold the marketing authorisation on your behalf. 
  • Ensures full compliance with EU/UK legislation, UK Medicines and Healthcare products Regulatory Agency (MHRA)/European Medicines Agency (EMA) guidelines and the terms of the marketing authorisation. 
  • Is accountable for pharmacovigilance, product quality and regulatory compliance. 
  • Ensures the product is manufactured, packaged and labelled according to good manufacturing practices (GMP). 
  • Maintains the quality management system (QMS) and oversees production — even if outsourced. 
  • Conducts audits and manages technical agreements to enable continuity of supply. 
  • Advises on good distribution practices (GDP) to ensure product integrity during storage and transport. 
  • Acts as a qualified person for pharmacovigilance (QPPV) and coordinates with pharmacovigilance teams for ongoing safety monitoring, signal detection and risk management. 

Find out more about appointing a marketing authorisation holder.  

Read our Commercial blogs

How to integrate early access programmes into your pharma market access strategy

Medical affairs vs drug commercialisation: understanding the line between science and sales

3 common MHRA marketing authorisation challenges (and how to solve them)

If you want to reduce the time, cost and other complexities associated with entering European markets, contact TMC Commercial today. 

Our flexible approach and deep expertise can help you gain marketing authorisation in the EU and UK — quickly and confidently — without losing control of your asset.