Powered by the efforts and diligence of our consultants, who have several years of pharmaceutical experiences in major companies, we offer the following short-listed services:

• Preparation of GMP Application Files

• Preparing registration/regulatory files in e-CTD (Common Technical Document) format

• Compliance Analyses (Detection of amendments/modifications/changes to PILs/SmPCs through examination of CDS, CCSI and PIL documents)
• Preparing applications for Type I and Type II variations

• Preparation and Application of SmPCs and PILs

• Drug Reimbursement Applications

• Preparation of Summary Bridging Reports on Product Safety

• Entry of companies into the Turkish National Databank of Medical Devices and Drugs – TİTUBB)

• Uploading documents and registering products at TİTUBB portal.

• Preparation of medical device labels

• Medical device reimbursement files (determining whether devices are in the positive listing of reimbursable products)

• Application for CE certificates (obtaining CE certificates from authorised bodies in case of absence)

Our regulatory services are not limited to the aforementioned. Please contact us for further details.