Regulatory Strategy

Bespoke regulatory services for optimal drug development

Regulatory consultants at Orphix analyse a client’s projects helping them to fully understand the regulatory environment by taking into account precedents and current regulatory thinking, advising on the best strategy and providing guidance on specific aspects of drug development. Orphix provides:

  • Data/dossier review and gap analysis
  • Regulatory development planning
  • Contact strategy, defining the appropriate timing of interaction, analysing the issues to be addressed and selecting the most suitable authority
  • Continued authority interaction to facilitate medicinal product development and marketing authorisation application