Regulatory Consultancy & Strategy

REGULATORY CONSULTANCY & STRATEGY

 

 

the+fda+is+under+pressure+to+expedite+its+approval+process+for+high+risk+medical+devices_3685_800489758_0_0_14005530_300PM Clinical’s Regulatory experts can provide support through all stages of drug development. We can help you put together a regulatory strategy document to determine your pathway forward.

Plans can be validated by preparing briefing documents and support through Regulatory Agency meetings both in Europe (nationally and with EMA) and in the US.

  • PM Clinical can manage your development program from the very early stages of development through to submission.
  • PM Clinical can support, evaluate and mentor your own regulatory function.
  • PM Clinical has particular expertise in orphan drug development and strategy and can prepare Orphan Drug Designations.