Tatyana Krotkova Email & Phone Number

Registration, re-registration, certification and declaration of Medical devices (according to ISO 13485, Directive 93/42/EEC and to the local legislation requirements and CIS-countries); Cosmetics, General products. The technical file preparation, art work design and etc. Preparation of regulatory strategies and identification of regulatory requirements for submissions. Providing support during internal and external audits.

Carrying out laboratory tests of the quality of medicines, substances, injection water for such indicators as microbiological purity, bioburden, sterility, quantitative content of mechanical particles, bacterial endotoxins (LAL test). Microbiological monitoring of production environment, control of personnel, research on the identification of microorganisms, working with pathogenic microorganisms. The work in the cleanliness class with a local zones A purity (sterility). Validation (aseptic and sterile).

Moscow

Implementation and improving all relevant systems to ensure compliance with ISO 9001 and with the national standards. Performs the function of a microbiologist for checking the quality of working surface and working environment. Research, preparing the technical documentation for projects, design the tests program.