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Our registration services

Preparation of:

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 productaccording 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 followingregistration applications or related variation applications

Registration renewal files of registered products

Co-Marketing application files