Naga Durgarao Koduri

WORK HISTORY

EDUCATION

SKILLS

ABOUT NAGA DURGARAO KODURI

Scientific Leader | E&L & Nitrosamine Expert | Biocompatibility | Regulatory Strategy | Analytical ChemistExperienced scientific leader with over 14 years of hands-on expertise in analytical chemistry, materials science, and global regulatory strategy. I specialize in building and leading Extractables & Leachables (E&L) laboratories to support pharmaceutical, medical device, and combination product development.I have successfully established GLP-compliant labs from the ground up—overseeing infrastructure, instrumentation, method development, and team training. My work has supported regulatory submissions to the FDA, EMA, PMDA, and Health Canada, with a strong track record of delivering high-quality, regulatory-ready data packages. Areas of Expertise Include:E&L & Nitrosamines: Led comprehensive E&L studies (PODP, OINDP, SUS, CCS) and developed validated LC-MS and GC-MS methods for nitrosamine detection and quantification, including NDSRIs in APIs, excipients, and packaging materials.Analytical Chemistry: Advanced expertise in LC-MS, GC-MS, HRMS, and chromatographic techniques for structural elucidation, impurity profiling, peptide characterization, and drug–device interaction studies.Regulatory Strategy: In-depth knowledge of FDA, EMA, ICH, USP, ISO 10993, and EU MDR. Experienced in preparing CMC documentation, risk assessments, and regulatory responses—including written and verbal interactions to address deficiencies.Biocompatibility & Risk Assessment: Designed and executed ISO 10993-1 assessments for Class I and II medical devices, integrating chemical characterization (ISO 10•••18) and toxicological risk assessment (ISO 10•••17).Cross-Functional Leadership: Strong collaborator across analytical, regulatory, quality, and toxicology teams to ensure product safety, regulatory alignment, and accelerated timelines.Instrumentation & Compliance: 14+ years of experience with HPLC, LC-MS, GC-FID, GC-MS, ICP-MS, NMR, FTIR, and UV-Vis. Skilled in method development, instrument troubleshooting, and ensuring GLP/cGMP-compliant operations.Team Development: Proven ability to lead, mentor, and grow high-performing scientific teams while fostering a collaborative and results-driven culture.I’m passionate about bridging science and regulation to drive innovation, ensure patient safety, and bring compliant, high-quality products to market efficiently.