UK Overview

Our market specific services for the UK

The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK regulatory authority. This agency is responsible for regulating all medicines and medical devices in the UK by ensuring they are efficacious and have an acceptable safety/risk profile.

 

 

Our UK based consultants can provide support and advice for all your project requirements.

Our services

Specific services provided by our team in the UK include:

 

  • Advice and interpretation of UK regulations
  • Interaction and meetings with MHRA
  • Regulatory support for clinical trials
  • Regulatory support for Marketing Authorization Application (MAA) submissions and life cycle management submissions
  • Compliance with the Association of the British Pharmaceutical Industry (ABPI) Code of Practice

 

 

 

  • ABPI signatory (copy approval) for promotional materials
  • Providing advice to marketing teams on product claims
  • Wholesaler dealers license applications (WDL) / Manufacturer/importer license (MIA)
  • Advice on setting up supply chains and distribution requirements
  • Attendance at MHRA scientific advice meetings
  • Pharmacovigilance support

Our experts

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