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 РУС ENG
office C115, 6 bldg.5 Barclaya str., 121087, Moscow, Russia
tel./fax: +7 (495) 74-88-777
info@mda-cro.com

Our
achievements

А тут будет сам Флэш

Our advantages

Our awards


    
  • Medical Development Agency was awarded with the social award Da Signa-2012 in the nomination «For application of the pharmacoeconomic studies’ results in real clinical practice»

Certificate of conformity

        
    • Operation quality is monitored by our Quality Management System that acts in accordance with GOST R ISO 9001 -2008 (ISO 9001:2008)

Main - Pharmaceutical Regulatory Affairs in Russia

Pharmaceutical Regulatory Affairs in Russia

Medical Development Agency has been operating since 2007. We have successfully  completed more than 250 regulatory affairs projects in Russia.

 

We provide full cycle of medicine registration, this process encompasses dossier evaluation for submission to Russian authorities, registration dossier translation and other activities.

 

 

Experience and professionalism plus knowledge of local regulations allow us to complete any task within reasonable timeline. 

 

High quality services provided by us have been highly appreciated by our clients with leading local and international pharmaceutical companies among. 

 

Our services in Russia include, whilst not limited to:

-  State registration, re-registration and amends in medical products and medical equipment

-  Adaptation of documentation to local regulatory authorities’ requirements

-  Conducting all necessary  preclinical, clinical and bioequivalent  trials for further registration procedure

-  Dossier evaluation for submission to Healthcare Ministry

-  Preparation of additional data for the request of local regulatory authorities;

-  Preparation of documentation for dietary supplements and pharmaceutical substances for further registration procedure

-  Dossier Evaluation and submission for listing in Russian National Essential Drug List

-  Conducting laboratory analysis of drug samples and pharmaceutical substances

-  Dissolution kinetics test for different doses

-  Documentation translation and notary certification

-  Gathering permission necessary to import drugs and reference substances in Russia for  registration procedure and conducting clinical and preclinical trials needs

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