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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

Phase I clinical trials, phase II clinical studies (phase IIa, phase IIb trials), bioequivalence studies in Russia by regulatory CRO Pharegis in Russia

Early Phases Clinical Trials in Russia

Conduction of early phases of clinical studies in Russia is not very common since only limited number of clinical centers satisfy strict criteria for the early clinical stages.

Nevertheless Pharegis provides to our clients full service managing Phase I and Phase II clinical studies. Also we have one of the biggest database on healthy volunteers in Russia who can meet criteria for entering those sophisticated studies for Phase I.

Like for Phase III, for Phase I and Phase II clinical study projects we provide full scope of CRO services:

  1. Project management – from feasibility & budget assessment and choosing of the sites to site closure and submission of clinical study report to MoH;
  2. Checking special conditions to meet clinical site criteria for Phase I and Phase II; providing site audit;
  3. Clinical study monitoring;
  4. Preparation of clinical study dossier and professional medical writing;
  5. Getting regulatory approval for clinical study, study protocol, protocol amendments and other documents approval;
  6. Data management and full-scope biostatistics management;

Request This email address is being protected from spambots. You need JavaScript enabled to view it. ll + 7 985 9085818 to get fast and free calculation of you study timeline and budget. Our experts will thoroughly analyse your project and then we discuss it in depth - that will bring you full understanding of the best way to move further. 

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News and press releases

  • Dutch authorities hand over final building to EMA in Amsterdam, , 15/11/2019
  • Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 November 2019 (updated), CHMP, 15/11/2019
  • EMA confirms Xeljanz to be used with caution in patients at high risk of blood clots, CHMP, 15/11/2019
  • Measures to minimise risk of serious side effects of multiple sclerosis medicine Lemtrada, CHMP, 15/11/2019