PREPARATION for GMP

Preparation for GMP

FOR TURKEY

Preparation of application forms for imported and domestic product licenses Preparation of export licenses files Preparing a commonly marketed product file Preparation of licenses transfer dossier Preparation of GMP files for imported products Preparation of change files for products that have been registered or have been registered

Type IA

Type IB

Type II

Preparation of license renewal files Preparing product information and instructions for use of a medicinal product of human use (from existing approved KÜB ve KT or original existing product prospect Preparation of bioequivalence summary report Preparation of 4 clinical expert reports

Medical devices preparation of application documents of medical devices with CE certificate and registration to the Turkish National Data Bank of Drugs and Medical Devices (TITUBB). Food supplies Preparation and follow-up of the application form for permission for food subsidies.

Veterinary medical products In accordance with the current regulations, guidelines and announcements issued by the Ministry of Agriculture, applications for veterinary medicinal products in accordance with the company's requests are prepared electronically or in the form of a written copy. The necessary information and documents for the application of marketing permission of the transactions related to veterinary medicinal products is prepared in accordance with the relevant legislation. It will be presented to the Ministry in an electronic environment.

Applications for marketing authorization, renewal applications, all variations apply, product specification summary and prospectus preparation.