Denys Ostapenko

Evaluation of the registration requirements on new markets Preparation of the registration dossiers under target country requirements for registration/ re registration/ changes submission Preparation of the answers for an official remarks of regulatory experts Communication with other departments specialists (R&D, Logistic, Designers etc.) for obtain successful results Calculation of the target prices of the medicinal products before registration Preparation of Confidentiality Agreements and Contracts

Preparation of the Registration Dossiers for registration/re registration/ change submission Submission of the Registration Dossiers to regulatory authorities Preparation of the answers for official remarks of the regulatory authorities Negotiate with regulatory experts to obtain correct decision for their remarks

Carrying out the analytical methods of control of API/intermediates/finished medicinal products Development of analytical methods and validation of analytical methods Was correspond for stability studies Prepared parts of the CTD dossiers