Sri Shruthi Komara, M.Sc Email & Phone Number

Ontario, Canada

India

• Prepared, compiled, reviewed, and submitted Dossiers for the USFDA, Health Canada, EMA, WHO in eCTD format consistent with regulatory requirements.• Filed Post approval submissions including amendments, annual updates, and annual reports, and handled life cycle management activities based on US FDA and Health Canada Regulatory guidelines.• Prepared responses to inquiries from various regulatory agencies such as the USFDA, Health Canada, WHO, EMA, and EDQM to support reviews of drug submissions.• Prepared Module 1, Module 2 Overview and Summaries, Module-3 Chemistry, Manufacturing, and Control (CMC) sections in accordance with regional requirements and identified potential deficiencies.• Engaged in reviewing Change Control systems for changes such as product labelling, manufacturing, packaging, and determined filing or notification requirements.

Hyderabad Area, India

Master Of Science, Regulatory Affairs

• Worked on drafting mock Premarket Approval (PMA), 510(k), de novo, IDE, Pre-Sub, NDA, Investigation Brochure (IB), PSURs, Letter.

Bachelor'S Degree, Bpharmacy