Madhushree Bugade

About Madhushree Bugade

I am a Regulatory Affairs professional with over 2 years of experience supporting global…

Experience

1. Regulatory Affairs Consultant

   Nuvo Consultancy

   Jan 2024 — Present · Mumbai, IN

   Prepared and reviewed Marketing Authorization Applications (MAAs) for oral solid dosage forms in the European market, ensuring full compliance with EMA regulatory requirements and guidance.• Managed the preparation, compilation, and maintenance of Drug Master Files (DMFs) and Active Substance Master Files (ASMFs) for APIs and excipients in the US and EU, including Annual Report preparation, submission, and follow-up.• Filed and maintained amendments for APIs and excipients to ensure ongoing regulatory compliance and alignment with current USFDA and EMA requirements.• Conducted detailed regulatory gap assessments for API and excipient DMFs, as well as tablet and injectable product dossiers, identifying areas of non-compliance and recommending corrective actions in line with USFDA, EMA, and ICH guidelines.• Drafted and delivered regulatory query responses in accordance with agency requirements.• Ensured compliance with global regulatory requirements, including those of the US Food and Drug Administration (USFDA), the European Medicines Agency (EMA), and other relevant health authorities.• Maintain and update internal regulatory databases and trackers, improving process efficiency and ensuring timely follow-up.