Clinical Development Planning

The TFS Global Clinical Development Team provides strategic advice on clinical development. TFS’ team of specialists in clinical development, early phase development, regulatory affairs, and medical experts in a broad range of therapeutic indications support our customers in their clinical development planning and implementation.

Our services include:

  • Scientific advice
  • Product development consulting
  • Proof of concept
  • PK/PD Modelling and simulation
  • Protocol design
  • Regulatory affairs strategy
  • Preparation and submission of CTA/ITA, IND, PMA/510(k)
  • Interaction with regulatory agencies world-wide
  • Orphan Drug Designations
  • Pediatric Investigational Plans (PIPs)