The Translational Research Group provides support on regulatory strategy.
The development of new technologies requires the ability to be able to navigate a range of regulatory hurdles to enable use in patients and for future market authorisation.
- Co-ordinate meetings with regulatory bodies (MHRA, FDA and EMA) to obtain both informal regulatory guidance and formal scientific advice.
- Advice on advanced therapy and medical device Classification, support for Orphan Drug Designation, Paediatric Investigation Plans and PRIME: priority medicine development.
- Support the timely development of Investigational Medicinal Product Dossiers and medical device Technical Files.
- Identify and engage with suitable external regulatory consultants.
Please contact us for free regulatory advice.