The Institute of Medical Biotechnology, affiliated structure of The State Research Center of Virology and Biotechnology VECTOR (Russia), was recently certified for its Quality Management Systems (QMS) in compliance with ISO 9001 standards in the fields of biological research and preclinical trials of drugs for human and veterinary medicine, cosmetics products, food and feed additives, pesticides, industrial chemicals, and other similar consumer goods. These improvements will allow the institute to reach new levels of business development and self-sustainability. 

Implementation of Quality Management Systems (QMS) started in 2006-2010 in the frame of ISTC project #3282 and was completed independently by our institute in the beginning of 2011. Various tasks were carried out in order to reach the project’s objectives: trainings of 23 staff members to ISO standards, internal audits in 9 departments, 18 workshops carried out, a quality assurance department was created, etc. The project was skillfully managed by Professor Valentina Masycheva who reached all milestones and her professionalism was praised by Foreign Collaborators.

"I am very pleased that we can now carry out preclinical trials according to international ISO standards. These new upgrades will allow us to have a more competitive position on the market. We thank the ISTC, the American Regulatory Affairs Professionals Society (RAPS), U.S. Department of State, CRDF, for their help in fulfilling the project. We greatly appreciate the assistance of the senior ISTC manager N.V. Savinova", said Prof Masycheva.

Adriaan van der Meer, ISTC Executive Director added "This is a good example of what ISTC is about. Creating sustainable jobs for Russian scientists and giving them tools to integrate commercial R&D. I am sure this will lead to further drug development and well being for Russian people." 

In the Russian Federation, Vector is one of the leading institutions in the fields of development and production of antiviral, antimicrobial, antitumor and immunostimuling drugs, vaccines and diagnostics. High level research is done on measles, influenza, HIV, hepatites A and B, polioyelitis, recombinant human cytokines, monoclonal antibodies, interferon, interferon inducers based on dsRNA, and much more.