Regulatory Support

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.