Hire Nishikant Nanasaheb Patil, a pharma consultant specializing in Analytical Testing, Clinical Studies 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: Nishikant Nanasaheb Patil is a pharmaceutical quality control and analytical documentation professional with experience in laboratory operations, development quality assurance, and regulatory documentation support. His expertise includes quality control, analytical method validation support, stability studies, GMP compliance, quality assurance, and investigation of laboratory deviations. He also supports development-related Chemistry, Manufacturing and Controls (CMC) documentation and regulatory filing activities through analytical document compilation and CTD Module 3 support. His background spans Titan Laboratories, Ultratech India, Brix Biopharma, and Medispray Laboratories. He helps pharmaceutical teams review analytical records, maintain traceable laboratory documentation, investigate out-of-specification results, and prepare quality and analytical information for audits and regulatory submissions. - Show More
Nishikant supports the analytical documentation component of CMC activities through CTD Module 3 documentation support. His experience includes review of specifications, analytical records, method validation documentation, and stability information. He helps teams compile and organize laboratory information for technical review and inclusion in regulatory submission documentation.
Nishikant supports investigation of laboratory deviations and out-of-specification results through review of analytical information and identification of potential root causes. His experience includes collaboration with QA, production, and R&D teams to resolve quality issues. He helps teams document investigation findings and support corrective actions addressing laboratory compliance concerns.
Nishikant supports laboratory GMP compliance through analytical documentation review, adherence to approved procedures, and application of Good Documentation Practices. His experience includes pharmacopoeial requirements, data integrity, and ALCOA+ principles. He also assists with audit preparation by organizing laboratory records and providing supporting analytical documentation for internal, customer, and regulatory reviews.
Nishikant supports analytical method validation activities and review of associated protocols, reports, worksheets, and raw data. His experience includes validation support in QC laboratories and review of analytical method validation records within development quality assurance. He helps teams assess documentation completeness and alignment with applicable ICH guidelines and laboratory procedures.
Nishikant provides analytical quality assurance support through review of development laboratory records, worksheets, reports, and raw data. His experience includes reviewing SOPs, specifications, method validation records, stability data, and QbD trial documentation. He works with laboratory and quality teams to identify documentation gaps and strengthen the traceability of analytical information.
Nishikant supports pharmaceutical quality control through sample analysis, analytical result review, and verification against approved specifications and pharmacopoeial standards. His experience includes maintaining certificates of analysis, laboratory records, logbooks, and test reports. He helps laboratory teams maintain complete, accurate, and traceable analytical documentation supporting product quality and audit preparation.
Nishikant supports regulatory filing activities through compilation and review of analytical documents for submissions. His experience includes CTD Module 3 support and preparation of laboratory records, specifications, validation documentation, and stability information. He assists quality and regulatory teams in assembling accurate, traceable analytical documentation supporting submission requirements.
Nishikant supports stability studies through generation, interpretation, and review of analytical stability data. His experience includes stability protocols, reports, trend review, and review of photostability records within analytical development. He helps teams maintain organized stability documentation supporting product lifecycle activities and regulatory submissions.
