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Regulatory Affairs Services

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