Product and Clinical Development

Design Perfection

  • Product Development Strategy and processes for in vivo radiopharmaceuticals
  • Concept to launch strategy for molecular diagnostics
  • Concept to launch strategy for point of care and near patient testing of immunodiagnostics.
  • Diagnostic product commercialization strategies for global sales
  • Building Research and Development teams for SME
  • Building commercial teams for first product launch for SME.

Clinical Strategy

  • 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.