Hire Dr. Vijay Waingankar, a pharma consultant specializing in Clinical Studies, FDA Inspections, Medical Devices, Pharmaceutical Manufacturing and Pharmaceutical Quality. See services offered, experience summary, and connect via apicule.
Based in: India
Willing to work in: India
Consultant Type: Independent Consultant
Expertise summary: Dr. Vijay S. Waingankar is a pharmaceutical quality assurance and regulatory affairs consultant with 35+ years of experience across APIs and formulations for regulated markets. His expertise spans cGMP quality systems, regulatory filings, CMC documentation, audit readiness, third-party and customer audits, CAPA, investigations, validations, vendor compliance, and remediation support. He brings strong hands-on experience in supporting global submissions, strengthening compliance programs, leading quality initiatives, and helping organizations prepare for regulatory inspections and sustained market approvals. - Show More
Dr. Vijay supports CMC activities for APIs and formulations with strong experience in technical documentation, dossier review, and regulatory submission support for regulated markets. His work includes review and compilation of CMC documents, alignment of manufacturing and quality information with regulatory requirements, coordination with cross-functional teams, and support for global filings in CTD and eCTD formats. He helps organizations strengthen the technical and compliance quality of CMC packages while improving readiness for regulatory review and market approvals.
Dr. Vijay supports equipment qualification as part of broader pharmaceutical quality and validation systems in regulated manufacturing environments. His experience includes review and approval of validation protocols, implementation of quality systems, qualification oversight, and support for compliance documentation linked to manufacturing, QC, and QA operations. He helps organizations maintain structured qualification practices that align with cGMP expectations and support inspection readiness, process control, and sustainable compliance.
Dr. Vijay supports FDA-483 response and remediation by helping organizations assess observations, strengthen quality systems, and implement corrective actions that address underlying compliance gaps. His experience includes CAPA follow-up, root cause analysis, investigation handling, review of implementation status through quality audits, remediation for import alerts, and development of mitigation and remedial action plans. He helps organizations move from observation response to more sustainable compliance control and improved inspection readiness.
Dr. Vijay supports the development, review, and strengthening of quality management systems across pharmaceutical operations. His experience includes internal audit planning, CAPA follow-up, complaint handling, root cause analysis, deviations, investigations, trend review, APQR, vendor qualification, and continuous compliance management. He helps organizations build practical and audit-ready quality systems that improve regulatory alignment, operational control, and long-term compliance performance.
Dr. Vijay supports regulatory filing activities for APIs and formulations across multiple regulated and international markets. His experience includes DMFs, CTD and eCTD submissions, CEP-related work, query responses, dossier preparation, technical document review, lifecycle updates, and coordination of regulatory information for market registrations. He helps organizations improve filing quality, submission readiness, and regulatory communication while supporting timely approvals and ongoing compliance obligations.
Dr. Vijay supports third-party GMP audits through extensive experience in customer audits, supplier audits, contractor assessments, internal quality audit planning, and review of compliance implementation status. He has worked on facility audits, gap analysis, system review, vendor qualification, and audit follow-up actions to help organizations strengthen external oversight and maintain regulatory confidence across their supply and manufacturing networks. He brings a practical, compliance-driven approach that helps companies identify gaps early and improve audit outcomes.
