Regulatory Affairs

Pharma IT offer Regulatory Affairs consulting services to support early phase drug development until maintenance of Marketing Authorizations.

Example of services:

  • Regulatory Strategy
  • Regulatory pathway analysis
  • Precedence within therapeutic area and technology
  • Competitor products overview
  • Regulatory guidance
  • Regulatory regulations and directives
  • Prepare regulatory documents
  • Variation management

Currently services are provided via our partners and via our extensive freelance consultant database.

If you need support don’t hesitate to contact us.