Regulatory Affairs

Our Regulatory Affairs team have extensive regulatory expertise encompassing new chemical and biological entities, as well as medicinal products containing established active ingredients, generic compounds and therapies for orphan indications.

We can assist in the formulation of a regulatory strategy to move your compound through to approval and, with established relationships with regulatory agencies, we are ideally placed to support you with your submission activities and at agency meetings.

We are well practised in the writing, review and submission of high quality regulatory documents, including:

 

  • Investigational Medicinal Product Dossiers (IMPDs)
  • Investigator Brochure (IBs)
  • EU Clinical Trial Authorisation (CTA) applications
  • US Investigational New Drug (IND) dossiers
  • Common Technical Document (CTD) Overviews and Summaries
  • Marketing Authorisation Applications (MAAs)
  • New Drug Applications (NDAs)