Speakers

Rashmi Shetty brings 28 years of extensive experience in the pharmaceutical industry, specializing in Quality Assurance and Regulatory Affairs. Throughout her career, she has made significant contributions to various companies, focusing on strategic regulatory decision-making, new product submissions, and life-cycle management.

In her current role, Rashmi leads and manages teams to develop and execute strategies for regulatory submissions, ensuring high-quality submissions and effective regulatory support for formulation, analytical development, and manufacturing units. Her expertise includes preparing comprehensive strategy documents and navigating complex regulatory frameworks.

Rashmi has a deep understanding of US regulatory submissions, including New Drug Applications (NDA), Abbreviated New Drug Applications (ANDA), and Abbreviated New Drug Submissions (ANDS). She is well-versed in the FDA regulatory process and has a proven track record of securing FDA approvals for a wide range of dosage forms, such as solid, liquid, topical, parenteral, ophthalmic, respiratory inhalation, peptides, and nasal sprays. Additionally, Rashmi handles regulatory submissions in Canada, ensuring adherence to Health Canada regulations.