Hire Rajeev Singh Rana, 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: Rajeev Singh Rana is an experienced pharmaceutical Quality, Compliance, and Operations professional with more than 33 years of industry experience across drug products, APIs, sterile manufacturing, oral solid dosage forms, injectables, and other pharmaceutical operations. His expertise includes Quality Management Systems, GMP audits, regulatory inspection readiness, supplier qualification, analytical method development and validation, stability studies, cleaning validation, equipment qualification, technology transfer, CMC documentation, and regulatory compliance. He has supported facilities inspected by major international regulatory authorities including USFDA, BfArM, ANVISA, EDQM, TGA, and PMDA and has held senior QA/QC leadership positions across multiple pharmaceutical organizations. His experience also includes gap assessments, due diligence, remediation planning, greenfield and brownfield projects, vendor quality assurance, aseptic manufacturing, and implementation of quality systems, enabling him to support organizations with practical compliance improvement and regulatory preparedness. - Show More
Rajeev supports analytical development through experience in analytical method development, technology transfer, QC laboratory operations, and review of analytical specifications and testing procedures. His background includes analytical methods for pharmaceutical products and APIs, regulatory laboratory compliance, and transfer of methods from R&D to commercial Quality Control laboratories.
Rajeev supports CMC activities through extensive experience across pharmaceutical manufacturing, Quality Assurance, Quality Control, analytical development, technology transfer, stability, validation, and regulatory submission activities. His experience with CMC data submission and coordination of manufacturing and analytical information enables him to support the preparation and review of technical information required for regulatory applications.
Rajeev provides GMP audit support based on extensive experience conducting gap assessments, due diligence, mock audits, and GMP audits across pharmaceutical manufacturing environments. His background includes evaluating quality systems, plant infrastructure, manufacturing operations, documentation, material and personnel flows, laboratories, and qualification activities. He can help organizations identify compliance gaps and develop practical remediation plans to strengthen audit and inspection readiness.
Rajeev supports pharmaceutical organizations with GMP compliance across manufacturing, Quality Assurance, Quality Control, and facility operations. His experience includes maintaining inspection readiness, closing regulatory observations, implementing CAPA, deviations, change controls, complaints, and quality-risk-management systems, and supporting regulated-market manufacturing sites.
Rajeev has extensive experience with analytical method validation and verification across pharmaceutical Quality Control and development environments. His work has included method-validation protocols and reports, specification and STP review, technology transfer, analytical laboratory compliance, and application of pharmacopoeial and ICH requirements.
Rajeev has extensive hands-on experience establishing, implementing, and maintaining pharmaceutical Quality Management Systems. His expertise covers deviations, change control, OOS/OOT, vendor qualification, complaints, CAPA, audit observations, SOP management, training, and electronic QMS platforms. He can assist organizations in evaluating existing systems, identifying gaps, and strengthening QMS effectiveness and regulatory readiness.
Rajeev has experience supporting regulatory submissions and successful dossier filing for pharmaceutical products intended for regulated markets. His background includes CMC data submission, regulatory approvals, responses to authority observations, remediation planning, and support for facilities supplying products to the US, EU, Brazil, Australia, Japan, and other international markets.
Rajeev has strong experience in Vendor Quality Assurance, including assessment, inspection, quality agreements, approval or rejection of suppliers, and periodic vendor review. His experience covers APIs, excipients, and packaging materials and includes coordination with supply-chain teams, making supplier qualification one of his clearly demonstrated areas of expertise.
Rajeev offers independent third-party GMP auditing services for pharmaceutical organizations requiring experienced external compliance assessment. As a Quality Compliance Expert, GMP Auditor, and CQI-IRCA certified Lead Auditor, he can independently evaluate manufacturing facilities, quality systems, documentation, vendor controls, and regulatory compliance and provide actionable recommendations for remediation and continuous improvement.
