Our regulatory affairs experts work with you to ensure a seamless submission and approval process for clinical trial applications.

We prepare and submit:

  • Clinical Trial Authorisation (CTA) applications to the MHRA, with an average approval time of just 15 days
  • documentation to research ethics committees, working with multiple committees across the UK to ensure timely approval
  • and applications to the Administration of Radioactive Substances Advisory Committee (ARSAC) for studies requiring dosing of ionising radiation to human volunteers

Our services also include:

  • writing and review of Investigational Medicinal Product Dossiers (IMPDs)
  • arranging scientific advice meetings with the MHRA
  • writing and review of Investigator Brochures (IBs)
  • advice on pre-clinical or clinical data requirements
  • general advice on the UK regulatory process
  • and preparing regulatory material for all clinical trials

Please enter your name and email to download the document

First Name (required)

Last Name (required)

Job Title (required)

Company (required)

City (required)

Country (required)

Your Email (required)