Regulatory Affairs Services

Regulatory Consulting

Regulatory Consulting

All Regulatory Services shall be conducted by our experienced specialists in Regulatory Affairs.

  • Dossier preparation and submission to the Turkish Medicines and Medical Devices Agency (TİTCK) and follow-up of procedures
  • Start-Up Services
  • Determining missing document for CTD applications (Gap Analyses)
  • Determining missing document for CTD applications (Gap Analyses)
  • Participating in teleconferences and video conferences where necessary to enable the flow of information for relevant projects
  • Correspondence with the Ministry of Health
  • Responding to letters regarding missing information
  • Ensuring the lifecycle of the product