Parvathi Mandapati

Biography

Parvathi Mandapati is working as senior executive-Regulatory Affairs in biocon.She completed her masters in pharmacology. Her area of specialisation: •Preparation of Registration dossiers (CTD/ACTD/ PSF/ Country Specific Dossiers) as per regulatory requirements in various ROW countries in Asia, Africa, Middle East, Latin American and CIS regions. •Supporting in handling of post submission Queries / Deficiencies received from clients / regulatory authorities within the stipulated timelines. •Coordination with Marketing, QA / QC / Production / Clinical / R&D and other departments for requisite data generation, review of documents for preparing the registration dossier. •Product Registration through WHO suggested ERP Process in various countries, which have implemented this procedure through Fast Track Registration. •Tracking the changes in Quality systems and updating the Master Dossier in timely manner to ensure that the dossier is prepared as per the current information. •Review of key submission documents received from cross functional teams. •Preparation of documents for Tender submission and Company registration. •Supporting RA Team lead in designing and executing regulatory strategies & timelines for projects & regulatory submissions in the assigned customer markets.

Research Interest

Pharmacology