Dr. R. Prem Kumar is a Delhi based Consultant for Vaccines, Pharmaceuticals and Medical devices with more than 27 years of rich Experience in the areas of Operation, Quality Control, Quality Assurance, Quality Audit, Inspections, R&D, Training and Consultancy. He is experienced in the preparation of various documents for Pharmaceutical and Biopharmaceutical establishments for the submission to the Regulatory Authorities. He is well-versed with ICH, WHO, EU and USFDA quality systems and regulations. He has served the Dept. of Biotechnology, Ministry of Science and Technology, Ministry of Health and Family welfare,various MNCs, Test Laboratories Consultancy and Inspection Organizations. Dr Kumar is also a vivid trainer who has mentored Student trainees from various Universities, Technical stall and the Medical officers alike in the past. His other capabilities include Project/Product Development and Planning and Management. He has now been working as a Freelance Consultant in the areas of Regulatory submissions, Quality Assurance and Higher Education.