Isha Patel

- Designed a thorough regulatory plan for the nuBeam Suite, a new Class III medical device that uses Boron Neutron Capture Therapy (BNCT) to treat recurring head and neck malignancies, for the U.S. FDA. - Created the IND route components and eCTD structure in accordance with 21 CFR Part 312 and drafted the regulatory strategy for BPA-F (L-Boronophenylalanine–Fructose Complex). - Analyzed and fixed MDSAP audit nonconformities, supporting risk-based design control alignment, document control enhancements, and CAPA planning. - Created compliance strategies for post-market labeling and traceability, including field correction preparedness (21 CFR 806), adverse event reporting (21 CFR 803), and UDI integration (21 CFR 830). - Developed quality remediation protocols for design input/output traceability, guaranteeing FDA audit readiness and DHF/DMR completeness in accordance with 21 CFR 820.30 &.181. (As a requirement for my Master's degree at Northeastern University, I worked with Neutron Therapeutics on this project.)

- Drafted and reviewed regulatory documents, including batch records, deviation reports, and quality control documentation, ensuring compliance with 21 CFR part 211 and ICH Q7. - Supported cross-functional teams (Quality Control and Quality Assurance) in preparing for internal and external audits, aligning with CDSCO, FDA and ICH Q10 regulatory frameworks. - Investigated and documented 10+ quality deviations and contributed to corrective action plans in compliance with ICH Q9. - Conducted analytical testing on 50+ samples of raw materials, in-process products, and finished goods using disintegration and dissolution apparatuses, ensuring compliance with IP and USP standards.