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Regulatory Affairs Services in Russia and Eurasian Union: Five Arguments for Pharegis

If you are planning to enter Russian or EAEU 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 EAEU.

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, Federal Service for Surveillance in Healthcare (Roszdravnadzor), Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ (FSBI ‘SCEEMP’) and every other expertise authority responsible for registration of pharmaceuticals and medical devices in Russia.

2. Client-oriented flexibility

We are dedicated to providing outstanding services to our Customers. 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, a customer can get that step readjusted for free.

Pharegis why choose us apple


Pharma Regulatory News

EMA News

  • Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 27-30 November 2023, PRAC, 01/12/2023
  • Consumption of antimicrobials in animals reaches lowest level ever in Europe, , 20/11/2023
  • Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 7-9 November 2023, CVMP, 10/11/2023
  • Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 6-9 November 2023, CHMP, 10/11/2023