Particularly in the healthcare and pharmaceutical sector, organizes seminars and trainings to meet the needs of different sectors by expert consultants and educators in firm and in service training.
Our team of experts that are dynamic and well trained and have been working with high experience and superior service. Medicinal products for human use with medical device’s which is status equivalent at pharmaceutical and medical device companies in the country and abroad provides consulting services in the field of regulatory affairs at every stage.
CTD Registration application files and e-CTD application including the modules 1-5 according to the requirements of the Ministry of Health
Evaluation reports identifying the deficiencies of the registration application files and providing technical assistance to the marketing authorization/licence holder in completing the information and documents that may be required by the Ministry of Health and follow-up until the approval from pre-inspection commission
Type I (A-B) and II (Quality, Clinical) variation application files of the human medicinal product according to the current Variation Guideline of the Ministry of Health
SmPC and PIL according to the current Guideline and SOPs of the Ministry of Health
GMP inspection files before the registration application Application files for the analysis of human medicinal products which require analysis following registration applications or related variation applications
Registration renewal files of registered products
Co-Marketing application files