Hire Manish L. Zanpure, a pharma consultant specializing in Analytical Testing, Clinical Studies, Pharmaceutical Manufacturing 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: Manish L. Zanpure is a pharmaceutical analytical research and development professional with experience across specialty formulations, oral solid dosage forms, ophthalmic products, oral liquids, and dermatological products. His expertise includes analytical development, method validation, stability programs, cleaning validation, quality control, GMP audits, and regulatory filing support. His career spans Alembic Pharmaceuticals, Lupin, Glenmark Pharmaceuticals, and FDC. He brings experience managing analytical activities from early development through commercialization, coordinating external laboratories, and transferring methods to quality control teams. His background also includes nitrosamine risk assessments, analytical control strategies, deviation investigations, and quality management systems. He helps pharmaceutical organizations resolve analytical challenges, strengthen laboratory practices, and prepare technical documentation for global regulatory submissions. - Show More
Manish supports analytical development for pharmaceutical formulations, including complex injectables, ophthalmic products, oral solids, and oral liquids. His experience covers methods for assay, degradation products, preservatives, dissolution, and identification, alongside product characterization and in-vitro studies. He helps teams develop analytical strategies, establish product specifications, troubleshoot methods, and coordinate analytical activities through scale-up and commercialization.
Manish supports cleaning validation through experience designing and coordinating cleaning validation activities within pharmaceutical analytical development. His background includes analytical method validation, protocol preparation, report review, and technical troubleshooting. He helps analytical and manufacturing teams plan supporting studies and review documentation for cleaning validation activities across products intended for different regulatory markets.
Manish supports deviation and laboratory investigation activities through experience handling deviations, out-of-specification results, quality notifications, and root-cause investigations. His work includes analytical troubleshooting and CAPA implementation. He helps teams assess technical findings, document investigation conclusions, and develop corrective actions addressing issues in laboratory testing and analytical development.
Manish supports GMP audits through experience conducting system audits of outsourced testing laboratories and coordinating cross-functional self-inspections. He has also participated in regulatory audit preparation as a core team member. He helps organizations assess laboratory practices, review analytical records, and prepare supporting documentation for internal, external laboratory, and regulatory assessments.
Manish supports analytical method validation, verification, equivalency, and comparison studies for pharmaceutical products. His experience includes planning validation activities, preparing and reviewing protocols and reports, and coordinating work with external laboratories. He also supports analytical method transfer and implementation in QC laboratories, helping teams address technical challenges throughout the analytical method lifecycle.
Manish supports pharmaceutical quality control through experience testing raw materials, packaging materials, in-process samples, finished products, and stability samples. His background includes analytical data review, instrument calibration, laboratory investigations, and method transfer from R&D to QC. He helps laboratories strengthen testing procedures, resolve analytical issues, and maintain consistent documentation practices.
Manish supports pharmaceutical quality management systems through experience handling change controls, deviations, investigations, and CAPA, alongside implementing analytical lifecycle management processes. His background includes SOP preparation, analytical documentation review, and coordination with CROs and CMOs. He helps teams maintain consistent quality procedures and manage analytical requirements across development, transfer, and routine laboratory operations.
Manish supports regulatory filing through preparation and review of analytical development reports, validation documentation, and technical responses to regulatory queries. His experience covers ANDA projects and submissions for markets including the United States, Europe, and Brazil. He helps regulatory teams organize analytical evidence and address questions related to methods, specifications, product changes, and supporting studies.
Manish supports pharmaceutical stability programs through analytical method development, stability sample testing, and preparation of supporting documentation. His experience includes ANDA stability studies and defining stability protocols informed by nitrosamine risk assessments. He helps development and quality teams coordinate testing requirements, review analytical findings, and
