Hire Dr. Nageswari Amasa, a pharma consultant specializing in Anlaytical Testing, Clinical Studies, Medical Devices and Pharmaceutical Quality. See services offered, experience summary, and connect via apicule.
Based in: India
Willing to work in: Global
Consultant Type: Independent Consultant
Expertise summary: Dr. Nageswari Amasa is an analytical R&D leader with 24+ years of experience across APIs and CDMO/CRO projects in the pharmaceutical industry. Her expertise includes analytical method development, ICH-compliant method validation, impurity profiling, stability studies, regulatory documentation support, and investigation of OOS, OOT, and method-related failures. She brings deep hands-on knowledge of advanced analytical techniques including HPLC, GC, LC-MS, GC-MS, ICP-MS, IR, and wet chemistry, along with strong experience in supporting analytical requirements from development through regulatory filing and commercial readiness. - Show More
Dr. Nageswari supports analytical development for APIs, intermediates, and CDMO projects through robust, stability-indicating methods designed to meet regulatory and operational requirements. Her experience includes overseeing analytical method development for assay, related substances, residual solvents, elemental impurities, wet analytical methods, polymorphism, chirality, and trace-level determination of genotoxic and nitrosamine impurities. She helps organizations build scientifically sound, cost-effective, and regulatory-aligned analytical approaches that support development, scale-up, technology transfer, and filing readiness.
Dr. Nageswari supports CAPA through a strong analytical and investigation-driven approach built on root cause analysis, troubleshooting, and site-wide risk mitigation. Her profile specifically highlights leadership in investigations of OOS, OOT, method failures, and stability failures, along with implementation of CAPA and mitigation strategies across analytical and quality systems. She helps organizations strengthen investigation quality, improve follow-up effectiveness, and translate analytical findings into sustainable corrective and preventive actions that support compliance, product quality, and long-term operational control.
Dr. Nageswari supports method validation through strong experience in ICH-compliant validation of analytical procedures for APIs and related products. Her profile highlights hands-on expertise in validation planning, execution, documentation, troubleshooting robustness and reproducibility issues, and transfer of validated methods to QC labs, manufacturing sites, and external partners. She helps organizations establish reliable and inspection-ready validation packages that improve analytical consistency, compliance, and lifecycle usability across development and commercial programs.
Dr. Nageswari supports pharmaceutical quality through broad experience in analytical R&D, regulatory compliance, GMP/GLP systems, stability programs, analytical reviews, and cross-functional support for API and CDMO projects. Her background includes oversight of analytical activities from development through regulatory filing, support for manufacturing and QC teams, data integrity compliance, SOP preparation and review, and alignment with global regulatory expectations. She helps organizations strengthen analytical quality systems, improve technical robustness, and maintain consistent compliance across development, validation, stability, and commercial support functions.
Dr. Nageswari supports regulatory filing activities by ensuring that analytical sections of DMF, ANDA, NDA, IND, CEP, and China DMF submissions are accurate, complete, and compliant with applicable guidelines. Her experience includes supporting regulatory queries, addressing deficiencies, and working with ICH, USP, EP, BP, FDA, EMA, ANVISA, and other expectations across global markets. She helps organizations strengthen filing quality through technically sound analytical documentation that aligns development data with regulatory submission requirements.
Dr. Nageswari supports stability studies across the API lifecycle, from indicative studies through commercial-stage programs. Her experience includes designing and monitoring stability studies, supporting forced degradation work, reviewing stability protocols, trending data, and ensuring alignment with ICH and internal quality requirements. She helps organizations strengthen stability strategy, data interpretation, packaging and re-test period decisions, and overall compliance of stability programs linked to development and regulatory commitments.
