Registration of drugs and pharmaceutical substances

General information

On the territory of Russian Federation Cultjurist Consulting Agency provides services of complete registration (alteration of registration documents) for medicinal products and pharmaceutical substances. We can assist at any stage of registration and alteration of registration documents, organization and support of all types of tests during the process of registration and certification.

Please, find the list of our services regarding registration: 

1. Registration of medicinal products and pharmaceutical substances.

2. Alteration of registration documents for medicinal products and pharmaceutical substances.

3. Setting up normative standard documents, pharmacopoeia articles of the company for medicinal products and pharmaceutical substances. 

4. Validation of analytical methods for medicinal products and pharmaceutical substances.

5. Organisation and coordination of pre-clinical research within registration procedure of medicinal products.

6. Organisation and coordination of registration clinical research within registration procedure of medicinal products.

7. Organisation and coordination of preliminary and other types of state control of medicinal products. 

8. Registration of bar-codes for medicinal product consumer packages in the Russian department of UNISCAN.

9. Registration of bar-codes for medicinal products from the “List of Necessary and Vitally Important Medicinal Products» (NVIMP).

10. Registration of prices of medicinal products from the “List of Necessary and Vitally Important Medicinal Products» (NVIMP).

11. Organisation and coordination of import for samples and standards  of medicinal products and pharmaceutical substances for conducting of pharmaceutical expertise and clinical research within the process of registration of medicinal products and pharmaceutical substances

12. Registration of trade marks regarding distribution of medicinal products within registration procedure of medicinal products.

Our consultants are ready to answer your individual questions regarding registration of medicinal products and pharmaceutical substances. Do not hesitate to contact us in case you need more information.