Regulatory Services

 

In our production facility; In addition to product development and production studies, licensing service is also provided in line with the requests of our business partners.

In this respect, we have been working for the relevant institutions in order to access your products to the market.

 

Human Medicinal Product Registration Application File Preparation

Contact with Active Substance and Auxiliary Substance Producers to obtain necessary documents (DMF, Certificate of Analysis, CEP, GMP etc.)

Compilation of the production documents of the preparation in coordination with the subcontractor in accordance with the prerequisites and legislation required for the License Application

 

Veterinary medical product Marketing Permit Application File Preparation

Product in CTD Format in accordance with Current Regulations and Guidelines with the data obtained Drug Analysis File

Preparation of the analysis files to be submitted to the Ministry upon request

 

   

Variation Files preparation and all documentation services

Determination of the deficiencies of your Type 1, Type IB and Type II change and variation application dossiers of human medicinal products in line with the current Variation Guide published by TİTCK and Ministry of Agriculture

Translation of required sections

Preparation of the variation file in accordance with the requirements of the relevant ministry

 

License Renewal preparation and all documentation services

Preparation of Veterinary Medical Product Registration File in e-Application Format Preparation of Part 3 and Part 4 Only Section 1 Preparation of C2 and 1 C3 expert report

Short Product Information Preparation, Prospectus, Internal-External Label Content Preparation

 

Social Security Institution Reimbursement File Preparation

Preparation, Presentation, Tracking of Reimbursement File

SITEMAP
© 2021 © TURKTIPSAN A.Ş ALL RIGHTS RESERVED