- making adjustments in the Module 3 “Quality” of MAD;

- knowledge of CTD requirements to structure and content of Module 2.3 “Quality overall summary” and Module 3 “Quality” of MAD;

- knowledge of guideline on biopharmaceutics classification system-based biowaivers and guideline on the investigation of bioequivalence;

- N-Nitrosamines Risk Evaluations in finished drugs;

- knowledge of Procedure under Article 5(3) of Regulation EC (No) 726/2004 Nitrosamine impurities in human medicinal products Procedure number: EMEA/H/A-5(3)/1490;

- reports on the polymorphism study (by XRPD, DSC) of the active pharmaceutical ingredients in finished drugs;

- reports on the validation of analytical methods of quality control (dissolution, related substances, assay, particles size etc.) of drug substances and finished drugs;

- reports on the compatibility of components study (active pharmaceutical ingredients, excipients and coatings) in the developing drugs;

- preparation of documents for stability studies of developed drugs in accordance with internal standard operating procedures.

- work with scientific databases;

- scientific projects development;

- preparing scientific articles and patents, presentations at the international conferences;

- synthesis and of inorganic materials with using of adsorption and spectral techniques (GC, XRPD, DSC, TGA, IR spectroscopy, TPR-H2, TPO-CO2).

Practical course of General and Inorganic Chemistry, supervision of Master students.