The team has experience in developing biomaterials from concept to finished products for clinical trials (especially those across the drug-device boundary). Key to this process is early consideration of regulations, ability to manufacture at scale and appropriate resourcing of projects. Some of the support we can provide covers:
- Advice on the pathway from bench to clinical trial: manufacturing, packaging and regulatory considerations for research stage projects
- Design of experiments to determine product feasibility
- Identification and engagement with appropriate third party companies: pre-clinical safety, transport, sterilisation etc.
- Preparation of regulatory documents such as MHRA Advisory Meeting briefing documents and Investigational Medicinal Product Dossiers (IMPD)
- Lab-based services: biomaterials, biochemical analysis, lab-grown tissues.