REGULATORY AFFAIRS


 

Your new solution partner in registration field!
 
 
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