1. J.RAMNIWAS
(M.Sc., M.Phil)
Global Quality Management and Regulatory Affairs
• Mr. J.Ramniwas has total more than 23 years of experience in various
Pharmaceutical industries as Global Quality Management and Regulatory Affairs
Professional.
• Since April,2009 onwards, Mr.J.Ramniwas has been the Chief Executive Officer
at Sai Pharma Solutions Inc. headquartered in Vadodara, India
• He has been responsible for GMP compliance, Regulatory Affairs and Quality
Management Compliance services to various clients of Sai Pharma Solutions Inc.
• He has held various management positions in many pharmaceutical organizations
such as Lupin Limited, Zandu, Zydus Cadila Healthcare Limited, Tonira Pharma
Limited and Tonira Chemical Company Limited, Titan Laboratories Pvt Limited.
• His experience includes Regulatory Affairs, Analytical Development, Analytical
Validations, Quality Control, Quality Assurance, Development and Establishment
of Quality Systems, GMP and Regulatory Affairs trainings, Qualifications and
Validations of Facilities, Equipments and Utilities, GMP Documentation,
Auditing, Regulatory Submissions, Hosting customer and Regulatory Audits, Risk
Management and Compliance to Global Regulatory Requirements
• Mr. J.Ramniwas has extensive experience of working with international
regulatory agencies, international associations such as USFDA, Health Canada,
EDQM, Korean FDA, ISO, MHLW, Japan and DIA,WHO etc. and multinational
customers such as Sandoz, TEVA, Polpharma, Almiral, Astellas Torii, Nippon,
Apotex, Corepharma Actavis, Takeda and Daichi Sankyo etc.
• He is a member of Drug Information Association (DIA), Indian Pharmaceutical
Association
• He is also making contribution for writing articles on burning issues in
pharmaceuticals and his articles have been published by the Express Pharma
Pulse, Pharma Times, Pharma Bio World, Pharma Guide and in-tech journal
• J.Ramniwas is representing India as a speaker and trainer for international
seminars on GMP, Regulatory Affairs and Quality Management Programs
conducted by IBC (Asia),Asia Business Forum, Malaysia, Singapore, Hong Kong
and Thailand, Global Regulatory Summits organized by CPhI etc.