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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

 Services and areas of expertise for drug registration, biosimilar registration, generic drugs registration, local clinical studies, bioequivalence studies, preclinical studies, pharma regulatory service in Russia provided by CRO Pharegis

Local CRO and Drug Regulatory Service Expertise

We have over 15 years of extensive experience with Russian Healthcare system namely Ministry of Health, Roszdravnadzor, State Center of Expertise and Control of Remedies for Medical Use and others. And we combine best planning and tactics to get your project done fast and without issues. Our way of communication with health authorities is based on high ethical standards. 100% of our experts and mamgers have higher medical or pharmaceutical background. We are adherent to anticorruption legislation and measures. And we guarantee you quality at every stage of our work.

Shortly, we provide full scope of exceptional quality service for you in following areas:

1. Elaboration of Regulatory Strategy. Regulatory Analysis and Consulting.

2. State Registration of Pharmaceuticals. Drug Renewals and Variations

3. Clinical Studies Management in Russia

4. Preclinical Studies Management

5. Certification and Declaration of Quality for Medical Drugs in Russia, EEU and Ukraine

6. Registration and Quality Certification of Medical Devices in Russiam EEU and Ukraine

7. Pharmacovigilance and Materiovigilance Management in Russia, EEU and Ukraine

You can trust us to get either full registration solution from sophisticated expert analysis in frames of initial free registration feasibility assessment to first import of registered product that will include preclinical adjustment and registration clinical study, or you can order to focus on specific process that you need to be finished fast and with high quality, nevertheless of grade and stage of that particular process.

You can send details of your question to This email address is being protected from spambots. You need JavaScript enabled to view it. to get fast and free:

  • Registration Feasibility Assessment;
  • Assessment of Registration Budget and Timeline;
  • Calculation of Clinical Study Budget and Timeline;
  • Calculation of Preclinical Study Budget and Timeline.

We will be pleased to help your business needs and send you our Clear Regulatory Answers.


News and press releases

  • Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 25-28 September 2023, PRAC, 29/09/2023
  • EMA recommends non-renewal of authorisation of multiple myeloma medicine Blenrep, CHMP, 15/09/2023
  • Towards a permanent collaboration framework for EMA and Health Technology Assessment bodies, , 15/09/2023
  • Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 September 2023, CHMP, 15/09/2023