12.Apr.2012

OCT has signed an agreement with a top ten Pharma for consultancy activities in Russia

OCT will assist a top ten pharmaceutical company with consultancy activities. This Company has been actively entering the Russian medicinal products market, which requires a full understanding of how it functions, under which regulations the market is developing, in what way legislative provisions should be implemented, etc.

OCT will assist a top ten pharmaceutical company with consultancy activities. This Company has been actively entering the Russian medicinal products market, which requires a full understanding of how it functions, under which regulations the market is developing, in what way legislative provisions should be implemented, etc.

The Company develops and markets new branded original drugs and generic products, both OTC as well as Rx, medical devices. Taking into account the great variability of the products, one should fully understand the way these products come to the registration in Russia. The following cornerstone legislative provisions constitute the basis for clinical trials of drugs:

  • Federal Law No. 61-FZ “On circulation of medicines” as of April 12, 2010
  • GOST R 52379-2005 “Good clinical practice”
  • Guidelines on Bioequivalence Assessment of Medical Drugs as of 2008
  • ICH-GCP Guidelines
  • US Code Federal Regulations, CFR Title 21 Food & Drug Administration revised as of April 1, 2006
  • and other applicable legislation, which also regards the important issues of patients / volunteers insurance, ethics provisions, import and export of study drugs / concomitant medication / biosamples, accreditation of medical institutions, quality control activities and measures, etc.

OCT has highly-qualified and widely experienced specialists in the following spheres and departments: