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Compliant and knowledgeable sponsor legal representation service

EU and UK Legal Representation

Acting as your EU and UK regulatory office.
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With offices in the UK and EU, we can provide comprehensive representative services tailored to your individual regulatory objectives and compliance needs, including:

  • Providing sponsor’s legal representative for clinical trials in EU/UK
  • Acting as your EU/UK legal office for regulatory purposes
  • Helping you obtain SME designation via our own regulatory SME status
EU and UK Legal Representation
Provide Sponsor’s Legal Representative for Clinical Trials in the EU and UK
Under the EU Clinical Trial Regulation (CTR), a sponsor wishing to conduct a clinical trial in the EU must either have a registered office in the EEA or appoint a representative based in the EEA to act as their legal representative.
The legal representative requirement applies to all clinical trials conducted to evaluate medicinal and/or pharmaceutical products and medical devices.
The clinical trial legal representative ensures compliance with the sponsor’s obligations under EU CTR and notifies the sponsor immediately if they become aware of non-compliance. Legal representatives act as agents of a sponsor for all communications regarding the Regulation.
For clinical trials in the UK, a sponsor must either be established in the UK or a country within the EU/EEA or appoint a legal representative based within the UK/EEA.
Act as your EU/UK office for regulatory purposes
To comply with EU/UK legislation, sponsors and/or Marketing Authorisation Holders must have a legal presence in the EU/UK to conduct clinical trials, pursue Orphan Drug Designations (ODD), secure Marketing Authorisations (MA), and receive Small and Medium-sized Enterprise (SME) benefits.
With offices in the UK and EU, we can provide a legal office for EMA/EU National Competent Authorities (NCAs) and MHRA liaisons.
Help you obtain SME designation via our own regulatory SME status
Pharmaceutical and Biotechnology businesses that meet the definition of a Small and Medium-sized Enterprise (SME) can apply to be registered as an SME by the European Medicines Agency (EMA). This offers significant savings in regulatory fees and other support from EMA.
If your enterprise is not yet legally established in the European Union (EU) or the European Economic Area (EEA), you can access SME incentives through our EU/EEA-established SME regulatory consultancy.

Need support for your clinical development project?

Do you need to troubleshoot regulatory or clinical trial issues?

Contact us today for an initial, free-of-charge discussion with a senior consultant about your project-related problems or issues.