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Our news

  • 18/07/2019: Pharegis implemented optimized procedures for state registration of pharmaceuticals in Eurasian Economic Union.
  • 20/06/2019: Pharegis updated timelines and practical approaches for Russian and EEU GMP inspection applications and procedures.
  • 03/04/2019:  Renewed general monographs of Russian state pharmacopeia XIV ed. have been analyzed.

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Regulatory Events Russia

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Russian Regulatory News

If you are planning to enter Russian or EEU market with a new pharmaceutical product, sophisticated medical device or just want to start selling your active pharmaceutical ingredients to Russian partners, maybe you already realized that finding time-efficient, fully predictable and transparent service provider, focused and dedicated to such projects in its experience would be optimal choice for your business with long-term impact and perspective. Here are main reasons for how any service solutions provided by us can be beneficial to your business in Russia and EEU.

Choose CRO for drug registration and approval in Russia, fast biosimilar and generics registration, managing local clinical studies, bioequivalence and therapeutic equivalence, preclinical studies, drug regulatory service in Russia - consider Pharegis

1. Focused experience

We have over 15 years of extensive experience working with Russian Healthcare system namely Ministry of Health, Roszdravnadzor, State Center of Expertise and Control of Remedies for Medical Use and every other expertise authority responsible for registration of pharmaceuticals and medical devices in Russia.

2. Client-oriented flexibility

We provide outstanding service to our clients 24/7. Any question that really concerns our  client can be discussed at top level with zero bureaucracy. We are trying our best to be flexible and compliant to client needs at first, not processes or our SOPs, yet sophisticated, specific and client-optimized.

3. Comprehensive expert approach

All our collaborators and experts are trained in international standards of business and international industry standards. 100% of our experts have higher medical or pharmaceutical education. Part of our staff have scientific degrees.

4. High ethical standards

Our ethics principles fully correspond to high industry standards established in top international companies. We are adherent to anticorruption legislation and measures. You can fully trust us on highly turbulent and Russian regulatory sphere.

5. Validity, predictability and quality of every process 

We guarantee quality at every stage of our work. Our rule is: if quality of service at any step is not 100% satisfying, client can get that step readjusted for free.

Pharegis why choose us apple


News and press releases

  • Towards a permanent collaboration framework for EMA and Health Technology Assessment bodies, , 15/09/2023
  • EMA recommends non-renewal of authorisation of multiple myeloma medicine Blenrep, CHMP, 15/09/2023
  • Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 September 2023, CHMP, 15/09/2023
  • EMA recommends non-renewal of authorisation of Duchenne muscular dystrophy medicine Translarna, CHMP, 15/09/2023