Our Regulatory Affairs staff 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 are well practised in the writing, review and submission of high quality regulatory documents, including:
- Investigational Medicinal Product Dossiers (IMPDs)
- Investigator Brochure (IBs)
- Common Technical Document (CTD) Overviews and Summaries
- US Investigational New Drug (IND) dossiers
- EU Clinical Trial Authorisation (CTA) applications
- Marketing Authorisation Applications (MAAs)
Regulatory Strategy - we can assist in the formulation of a regulatory strategy to move your compound through to approval or can manage the efficient implementation of an existing development plan.
Regulatory Submissions - we can assist with CTA/IND
applications, manage MAAs through to determination via the Centralised, Decentralised or Mutual Recognition procedures, and conduct
post-licence maintenance.
Agency Meetings - with established relationships with regulatory agencies, we are ideally placed to support you at agency meetings.
In-house Regulatory Support - if you prefer on-site support, we can provide regulatory staff to supplement your existing team.
Consultancy Services - for those occasional regulatory questions, we offer an ad hoc advice service, providing you with instant access to our regulatory expertise for individual queries.