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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

Preclinical studies, in vitro studies for drugs, generics and biopharmaceuticals by regulatory CRO Pharegis in Russia

In Vitro Preclinical Studies in Russia

are commonly used for several procedures like addition of new dosage (that require new registration procedure)

  1. Biowaver testing (test of comparative dissolution kinetics of drugs) for every dosage of a pharmaceutical to be registered;
  2. Comparative studies of antibiotic activity;
  3. Microbiology studies;
  4. Viral safety studies;
  5. Additional pharmacokinetic variables assessment as part of a clinical study;
  6. Patient genotyping for highly-variable metabolism pharmaceuticals in frames of bioequivalence or therapeutical equivalence studies;
  7. Pharmacogenetic studies.

 

Contact us today and we provide you free calculation and initial consultation on in vitro study budget and timeline. Our experts will discuss every detail of your project and you will receive working solution that will bring you Clear Regulatory Answers for Your Business.

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News and press releases

  • New measures to avoid potentially fatal dosing errors with methotrexate for inflammatory diseases, CHMP, 23/08/2019
  • EMA/FDA analysis shows high degree of alignment in marketing application decisions between EU and US, , 16/08/2019
  • EMA closed 15 August 2019 , , 13/08/2019
  • Supporting medicine developers in generating quality data packages in early access approaches (PRIME and breakthrough therapies): workshop report published , , 31/07/2019