Marharyta Palahniuk
Skills
Timeline
Professional experience for Marharyta Palahniuk
- Current 5 years and 10 months, since Feb 2020
Regulatory Affairs Specialist
LLC Organosyn Ltd
- Submitting dossiers of drugs supplement for applications to the authorities Ukraine, Uzbekistan, Kasachstan (CTD format, Module 1-5) - Transfer of registration materials to production sites - Evaluation and agreement of change protocols - Skills and knowledge improvement of ICH, US regulatory requirements - Expertise of DMF of substances and registration dossier of the finished medicinal product
- 5 years and 10 months, Apr 2014 - Jan 2020
R&D Chemikerin
Pharmaceutical company Darnitsa
- Development and validation of analytical methods of quality control drugs (medicines) and substances by HPLC, UPLS, TLC, Spectrophotometry, titration - Development and validation of MMD (CDP) procedures by HPLC, UPLS - Execution of protocols/reports of validation and MMD research - Pharmaceutical development assessment
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