Starting with the development of the Target Product Profile, LFSCNC can support you designing an overall strategic development program covering all critical phases:

  • Timelines and critical milestones of all clinical studies and regulatory submissions outlining the critical path

  • Dependencies supporting clinical studies such as availability of manufacturing data (stability programs, clinical batch manufacturing) and non-clinical data (supporting tox and or pharmacology studies)

  • FTE and cost calculations

  • Outsourcing solutions (CRO, CMO etc…)

 

In addition we have 15+ year experience in Project Management, so we can also co-ordinate your development program across the different functions within your company on a day-to-day operational basis.

"We just initiated our First-in-Human study and would like to further map out our  development program."

© 2020 by LFSCNC. LFSCNC is the trade name of HDH Consulting BVBA.