Krupa Zachariah

Krupa Zachariah is an associate in the Business Law department and a member of Goodwin’s Life Sciences Regulatory & Compliance practice. 

Krupa advises pharmaceutical, biotechnology, and healthcare clients on a wide range of regulatory and compliance matters involving the U.S. Food and Drug Administration (FDA). Her practice spans FDA enforcement and risk mitigation, manufacturing compliance, and regulatory support for corporate transactions. She also counsels clients on broader federal and state healthcare regulatory frameworks, including state-specific analyses of laws and codes that impact FDA-regulated operations across jurisdictions. 

• Provides regulatory diligence and strategic guidance in connection with complex life sciences transactions, including mergers and acquisitions. 
• Advises on regulatory disclosures and securities filings for pharmaceutical companies, including corporate presentations and press releases. 
• Counsels clients on compliance with current Good Manufacturing Practices (cGMPs), responds to FDA Form 483 observations and warning letters, and manages regulatory inquiries involving manufacturing operations or bioresearch monitoring. 
• Advises on Drug Supply Chain Security Act (DSCSA) requirements, Risk Evaluation and Mitigation Strategies (REMS), over-the-counter (OTC) drug regulations, and emerging issues in clinical research and FDA litigation. 
• Conducts licensing and permitting due diligence reviews to identify pre-closing and post-closing tasks associated with transactions involving FDA-regulated entities. 
• Advises on FDA regulatory matters in the negotiation of clinical trial agreements, supply agreements, and quality technical agreements. 

Krupa is a member of the Food and Drug Law Institute (FDLI). She completed her service on FDLI’s Medical Products Committee in 2024. She is currently serving on FDLI’s New to FDA Law and Regulation Planning Committee. 

Krupa completed the Planned Parenthood Metropolitan DC’s Developing Leaders Program.