Regulatory Affairs Services

Preparation and Revision of SmPCs/PILs

Preparation and Revision of SmPCs/PILs

Our expert team shall prepare or revise SmPCs/PILs in accordance with current guidelines in the format requested by the Turkish Medicines and Medical Devices Agency.

  • Revision of SmPCs/PILs according to global SmPCs
  • Preparation and revision of SmPCs/PILs according to the originator company for the generic product
  • Translation of necessary documents