Regulatory Affairs Services

Prescription/non-prescription medicinal products for human use registration dossier preparation/submission

Preparation of registration dossiers of prescription/non-prescription medicinal products for human use in CTD format in accordance with the current regulations and guidelines

Electronic submission of the registration dossier


Preparation of Type IA, Type IB, Tip II variation dossiers

Preparation of the variation application dossiers in accordance with the current variation guidelines

Electronic submission of the dossiers


Preparation of registration renewal application dossiers

Preparation of the pharmacovigilance data which is required for the registration renewal application dossier and preparation of 2.5 clinical summary section (for manufactured products)

Preparation of the registration renewal application dossiers in accordance with the current legislation and guidelines

Electronic submission of the dossiers


Preparation of license transfer application dossiers

Preparation of the license transfer application dossiers in accordance with the current legislation and guidelines

Electronic submission of the dossier


Preparation of Traditional Herbal Medicinal Products registration dossiers

Preparation of registration dossiers of traditional herbal medicinal products in OTD format in accordance with the current regulations and guidelines

Evaluation and completion of the feedback reports sent to the company by the Authority about the lacking parts of the dossiers

Electronic submission of the dossiers


Preparation of Veterinary Medicinal Products registration dossiers

Assesment of the registration dossiers of the veterinary medicinal products in terms of scope and format and preparation of the report about lacking parts

Translating the necessary parts of the dossier with appropriate registration terminology in accordance with the requirements of the Ministry of Agriculture

Preparation of the dossiers in accordance with the current legislations


Module 2.4 non-clinical summary and Module 2.5 clinical summary preparation

Preparation of module 2.4 non-clinical summary and module 2.5 clinical summary sections in accordance with the current regulations and guidelines


Last check of registration dossiers before submission
Translation of registration dossiers
SmPC-PIL preparation/ update/translation

Follow up of national/international regulatory affairs legislations and guidelines
Compliance with regulations and guidelines change


PIL Readability Test​​​​​​​

In line with the Ministry of Health Republic of Turkey regulation; we carry out your registration in accordance with the Law on the Protection of Personal Data (KVKK) in accordance with the Institution and EMA standards for the products whose licensing process is ongoing or which has been licensed after 14.07.2017 but has not received sales permission.

PIL (Personnal Information Leaflet)  Test service consists of the following processes.

  1. preparation of the protocol
  2. Discussion with selected sample group, which may be a potential user for testing the legibility of use instructions
  3. Analysis of results

  4. Preparation of detailed result report