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Regulatory Affairs

We can help you find answers to the big and the frustrating but often important small questions that arise in your regulatory and development strategies. Our experience of larger pharma and SME companies helps us to understand the broader challenges facing large organisations as well as the needs of the smaller, developing companies:

  • What is the best regulatory strategy to realise your business aims?
  • How do development studies dovetail with value inflexion points?
  • What will regulatory agency expectations be for your products and where are the likely pitfalls and major challenges?
  • Is your development strategy consistent with your business imperatives?
  • Design of development programmes and specific nonclinical and clinical studies.
  • Selection of CROs to conduct studies from Phase 1 to Phase 3.
  • “Hands-on” operational Regulatory Affairs and Clinical / Medical support.