Clinical Development

Clinical Development

  • 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.