Olga Golubovskaya
pharma
Khlopin Radium Institute
Russian Federation
Biography
Olga Golubovskaya Accomplished Analytical Sciences & Quality professional specializing in the pharmaceutical, biotechnology, and medical devices industries. Demonstrable history of project, laboratory and people management and ability to deliver on short and long-term goals. Experience overseeing projects from early development throughout Phase III/IV, registration, and post-approval stages for various dosage forms: solids (tablet/capsule/powder), parenteral, transdermal, MDI, and PET tracers. Wide-ranging knowledge of analytical technologies and their applications. In-depth understanding of global regulatory requirements, such as ICH, FDA,, and GxP guidelines.GxP Auditor. Preparation of several CTDs for IND and NDA filings as well as for IMPD, MAA. Skilled in managing clients projects working for contract organization.
Research Interest
pharma
