Rushikesh Kadu

WORK HISTORY

EDUCATION

ABOUT RUSHIKESH KADU

As a Regulatory Affairs Officer at BDA Pharma Pvt. Ltd, I specialize in ensuring compliance with regulatory standards and streamlining the approval process for pharmaceutical products. My role encompasses the preparation and meticulous review of dossiers in alignment with ICH guidelines and regulatory requirements of various authorities. Key responsibilities include: Preparation of Dossier in CTD and ACTD Format for ROW market Preparing and reviewing technical documents such as DMF, MFR, BMR, BPR, specifications, STP, COA, PDR, PVR, PVP and stability studies. Conducting brand name searches and verifying availability on Intellectual Property India sites. Developing and reviewing SmPCs, packaging materials, and patient information leaflets (PILs). Overseeing dossier submissions to regulatory authorities in Tanzania and Rwanda. Performing quality inspections of finished products to ensure they meet required standards before dispatch.