Global Regulatory Affairs

In Russia and other CIS markets, we are able to help you navigate the complex regulatory and commercial landscape.  With an operations office in Central and Eastern Europe (CEE) and a vendor network that covers the entire region, we are able to support you all the way.  

 

For example, in Russia there are 2 strictly divided categories of product: 

  1. Pharmaceutical products & 

  2. Food supplements and cosmetics  

The product must be associated with one from these categories.  To enter the Russian market, the registration dossier consists of sections:  

  1. Administrative documents 

  2. Description of pharmaceutical properties 

  3. Data about manufacturing of pharmaceutical product  

  4. Data about quality control of the finished pharmaceutical product  

  5. Data about PRE-CLINICAL pharmacological and toxicological studies of pharmaceutical product 

  6. Data about CLINICAL studies of pharmaceutical product  

It has a similar style to that of a European registration file but consists of one extra section.  If the manufacturer has European registration file, it is not necessary to prepare separated documents for Russia as all data required for Russian dossier is available in European file. The Russian registration file must be presented to State Regulatory Authorities in Russian language.  However, this does not mean that you can simply take a European CTD ad translate it!   

Where we add value is on our understanding of the Russian requirements, not just from a language perspective, and can provide accurate and professional gap analysis work to ensure that your dossier is suitable for a Russian or other CIS submission. 

We can advise and ensure that we mitigate possible difficulties such as the necessity to conduct additional tests on your finished product, managing importing of standards and samples and ensuring that your documents are compiled according to the finished product specification, European/British Pharmacopoeia, United States Pharmacopoeia and Russian Pharmacopoeia.  

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If you are interested in our service please contact us for more information.

Telephone+353 125 44033
Email: marketing@arriello.com

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