Regulatory

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

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