Hire Anil Kumar Dhiman, a pharma consultant specializing in Analytical Testing, 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: Anil Kumar Dhiman is a pharmaceutical quality professional with over 21 years of experience in laboratory operations across oral solid dosage, sterile, dry powder injection, and oncology manufacturing environments. His selected consulting services include analytical development, dissolution studies, FDA-483 response and remediation, GMP audits, method validation, and stability programs. His background spans Venus Remedies, Logos Pharma, Alkem Laboratories, Fresenius Kabi, and Cipla. He has led large laboratory teams, supported ANDA-related analytical activities, and represented QC functions during regulatory inspections. He helps pharmaceutical teams coordinate analytical work, review technical documentation, investigate laboratory discrepancies, and strengthen laboratory practices supporting product development and regulatory requirements. - Show More
Anil supports analytical development activities through coordination between QC, analytical development, and regulatory affairs teams. His experience includes analytical planning for ANDA projects, new product launches, exhibit batches, and method transfer. He helps teams review analytical documentation, resolve testing discrepancies, and establish laboratory readiness for development and commercial manufacturing activities.
Anil supports dissolution studies for oral solid dosage products, including planning and execution of studies across multiple dissolution media and dose-dumping assessments. His experience includes coordinating laboratory testing for ANDA projects and exhibit batches. He helps teams organize analytical activities and supporting documentation to meet product development and submission timelines.
Anil offers laboratory-focused support for FDA-483 response and remediation, drawing on his experience in regulatory inspections, analytical investigations, and CAPA implementation. His support focuses on reviewing relevant laboratory records, investigating analytical discrepancies, and organizing corrective action documentation to help manufacturers address QC-related observations.
Anil offers GMP audit support focused on pharmaceutical QC laboratories, drawing on his experience representing laboratory functions during international regulatory inspections. His work focuses on analytical documentation, data integrity, laboratory practices, and quality records. He helps teams identify compliance gaps and organize supporting evidence and corrective actions for audit follow-up.
Anil supports analytical method validation, verification, and transfer through technical oversight and review of laboratory documentation. His experience includes coordinating validation activities for finished products and explaining method validation records during regulatory inspections. He helps QC and analytical development teams establish laboratory readiness for transferred methods and commercial manufacturing.
Anil supports stability programs through oversight of stability testing, analytical planning, and associated documentation. His experience includes time-zero testing for exhibit batches and stability activities supporting ANDA projects and product lifecycle requirements. He helps teams coordinate testing priorities, review analytical findings, and maintain stability information for regulatory submissions.
