- Development of a clinical regulatory strategy for an Annex II List A registration in Europe for an SME biotech company in the USA.
- Clinical development programme and quality infrastructure to Good Clinical Practices for a UK satellite of a US headquartered life sciences company.
- Clinical submission strategies for FDA and clinical development plan for market access of a registered product for UK based SMEs.
- Set up and management of EU and US based clinical studies intended for regulatory submission.
- Prepare the required documentation and direct the meeting strategy for Pre-submission meetings with FDA.