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  • 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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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 co-chairs elected for working parties for healthcare professionals and for patients and consumers, , 23/09/2022
  • Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 September 2022, CHMP, 16/09/2022
  • Biosimilar medicines can be interchanged, CHMP, 19/09/2022
  • New medicine to protect babies and infants from respiratory syncytial virus (RSV) infection , CHMP, 16/09/2022
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