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.