Hire Mangesh H. Jagtap, a pharma consultant specializing in Analytical Testing, Clinical Studies, FDA Inspections 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: Mangesh H. Jagtap is a pharmaceutical analytical development and quality professional with over 27 years of experience across APIs and finished dosage forms, including oral solids, injectables, ophthalmics, and oral liquids. His expertise includes analytical development, method validation, stability programs, quality control, quality assurance, and quality management systems. He also supports GMP compliance, FDA inspection readiness, and analytical documentation for regulatory filings. His background includes analytical leadership roles at J.B. Chemicals & Pharmaceuticals, Jubilant Generics, Wockhardt, and ALS Analytical Solutions. Combining hands-on analytical expertise with laboratory management and technical review, he helps pharmaceutical teams develop and transfer methods, strengthen laboratory practices, investigate quality issues, and prepare documentation for regulatory submissions and inspections. - Show More
Mangesh supports analytical development for APIs, excipients, and finished dosage forms through analytical strategy, method development, impurity profiling, and forced degradation studies. His experience includes stability-indicating methods, pharmacopoeial method evaluation, and preparation of specifications and standard testing procedures. He also supports analytical troubleshooting and method transfer from development laboratories to manufacturing sites.
Mangesh supports FDA inspection readiness for analytical development and QC functions through laboratory gap assessments, documentation review, and preparation of technical responses. His experience includes analytical audit readiness, regulatory query support, and review of validation and qualification records. He helps teams identify laboratory compliance gaps and organize supporting evidence for inspection preparation.
Mangesh supports GMP compliance in analytical development and QC laboratories through gap assessments, technical documentation review, and improvement of laboratory practices. His experience includes cGMP, GLP, data integrity, and computerized-system compliance support. He helps teams review procedures, analytical records, and instrument documentation to identify deficiencies and prioritize corrective actions.
Mangesh supports analytical method validation, verification, and transfer for APIs and pharmaceutical formulations. His experience includes reviewing protocols, analytical methods, validation reports, and supporting data across multiple dosage forms. He helps development and quality control teams establish documented method performance and coordinate transfer activities between laboratories and manufacturing locations.
Mangesh provides quality assurance support for analytical laboratories and pharmaceutical operations through review of SOPs, protocols, reports, and quality records. His work includes validation oversight, data integrity practices, risk assessments, and investigation support. He helps teams strengthen documentation traceability and align analytical and laboratory activities with established quality requirements.
Mangesh supports QC laboratory operations through analytical troubleshooting, data review, specification and testing procedure review, and laboratory workflow improvement. His experience includes oversight of instrument qualification, calibration, and maintenance documentation. He also helps laboratories coordinate testing activities, manage analytical resources, and strengthen documentation practices across routine and development-related testing.
Mangesh supports pharmaceutical quality management systems covering deviations, out-of-specification and out-of-trend results, CAPA, change control, risk assessment, and document control. His consulting experience includes QA/QC system improvement and analytical compliance oversight. He helps organizations review quality processes, investigate findings, and document corrective and preventive actions.
Mangesh supports regulatory filing activities through preparation and review of analytical documentation for APIs and finished dosage forms. His experience includes analytical programs associated with ANDA submissions, DMF review, and responses to regulatory deficiencies. He helps teams review specifications, testing procedures, validation reports, and stability information supporting regulated-market submissions.
Mangesh supports pharmaceutical stability programs through stability testing oversight, analytical data review, and development of stability-indicating methods. His experience covers APIs and finished dosage forms, including oral solids and parenterals. He helps teams review stability study documentation, assess analytical results, and address method-related issues supporting product development and regulatory activities.
