Bhaumik Modi

Background

About Bhaumik Modi

1 / 2 * Regulatory Affairs Leader | ANDA & 505(b)(2) Strategist | 20+ Years | US FDA CDER-Focused Submissions With two decades of hands-on experience, I specialize in US FDA regulatory submissions, focusing on ANDA and 505(b)(2) applications across a wide range of dosage forms, including oral solids, injectables, topicals, and complex generics.* Track Record: 200+ regulatory filings to CDER High first-cycle approval rates. Efficiently handling queries, performing due diligence and risk assessment.* Deep expertise in eCTD, bioequivalence, and QbD-driven submissions What I Offer: Regulatory strategy design for generics and 505(b)(2) Gap analysis and risk mitigation before filing Pre-submission meeting prep (Pre-IND, iPSP, Pre Dev, Pre Sub etc.) Responses to FDA deficiencies (CRLs, IRs) Dossier audits and lifecycle management support 🤝 I work closely with startups, CDMOs, and mid-sized pharma to navigate complex US submissions, reduce review cycles, and improve success rates. Also active as a trainer/mentor, helping the next generation of regulatory professionals understand real-world application strategies. Let’s connect if you’re looking for hands-on US FDA expertise that drives faster approvals and lower regulatory risk.