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)
