Commercialise your products in the UK and EU — without a local legal entity 

Acting as a marketing authorisation holder (MAH) requires specific qualifications, knowledge and a legal entity within the relevant region, which is why you won’t see many clinical research organisations (CROs) offering this service. Our MAH service sets us apart from other CROs.  

Biotech and pharmaceutical companies face substantial regulatory hurdles when bringing new therapies and products to market. The MAH function is critical in ensuring your product consistently meets the stringent safety, efficacy and quality standards required by regulatory authorities, enabling you to bring it to market successfully. 

From initial regulatory submissions and clinical trial oversight to post-approval regulatory affairs, TMC provides a strategic role through every stage of drug development. Our presence in the UK and EU allows you to commercialise products in these regions or globally without needing local legal entities — reducing the time, cost and other complexities associated with entering new markets. 

Get support through every stage of drug development 

As your MAH, we’ll:  

  • Assume all risks and responsibilities to hold the marketing authorisation on your behalf — either in designated regions or globally. 
  • Take full responsibility for product life cycle regulatory compliance, including post-marketing obligations. 
  • Consult on optimal launch strategies, regulatory submission timelines and pathways. 
  • Coordinate with pharmacovigilance teams for ongoing safety monitoring, signal detection and risk management. 
  • Provide a European qualified person for pharmacovigilance (QPPV) or a qualified person in the EU for medicinal product batch release (MPBR).  
  • Become the primary contact for health authorities, including the UK Medicines and Healthcare products Regulatory Agency (MHRA) and European Medicines Agency (EMA)

Access submission fee discounts through TMC’s EMA-recognised SME status 

The EU is an attractive market opportunity for biotech or pharmaceutical companies. However, obtaining EMA new drug approvals can be a complex and lengthy process, particularly for orphan drug designations. 

From 1 January 2025, the EMA implemented the EU Regulation 2024/568 on fees for regulatory submissions. This change comes with a significant increase in some of the fees payable to the EMA for scientific assessment of a medicinal product for the application of a marketing authorisation, variation or authorised product. 

As an established EU/EEA-based marketing authorisation holder with SME status, TMC can be your EU/EEA representative, ensuring compliance with all local regulations while securing substantial discounts on your EMA fees. 

To improve your chances of gaining market authorisation approval, find out more about appointing a marketing authorisation holder or contact us today to see how we support you through the process.