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  • 04/07/2017: Pharegis analytics: advantages and possibilities of Eurasian Economic Union (EEU) 2017 requirements for registration of medical drugs and devices.
  • 03/30/2017: Pharegis analytics: Russian GMP inspections - possibilities and key elements.
  • 05/20/2016: Pharegis implemented full integration of Russian GMP services to API and finished product registration services.

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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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