Regulatory Science

Synavia helps you find and keep an optimal regulatory pathway via:

• Expert support for pre-registration activities and registration process
• Appropriate selection of legal base for your MAA
• Activities and services:
  • Scientific Advice support
  • Medical writing activities
  • Responses to deficiency letters
  • Support during break-out sessions and referrals
• Up-to-date information, news and updates from regulatory world
• Targeting specific requirements and expertise of individual national competent authorities (NCAs)
• Active contribution in creation and revisions of the  guidelines by means of public comment
• Referrals – preparation of response documents, documentation and support
• Assistance during meetings with EMA and Local Authorities in Europe