– Evaluation of the license files planned to be licensed in terms of scope and format, preparation of the deficiency report

– Translation of the necessary parts in accordance with the regulatory terminology

– Preparation of short product information (SPC) and instructions for use (KT) in accordance with the legislation

– Preparation of the file in CTD format (modules 1-5) in accordance with current legislation

– Preparation of Module 2.4 Non-Clinical Summary and Module 2.5 Clinical Summary Sections

– Preparation of Variation (Type IA, Type IB, Type II) Files

– Electronic application of the file

– Providing technical support in completing the information and documents to be requested by the Ministry of Health.