Dr. Rajen Shah is the founder and Director of Raptim. He is a Ph.D. from the University of Maryland (US), and a Bachelor in Pharmacy.
Dr. Rajen Shah has worked in the research group of Global Pharmaceutical companies like Novartis in the US and Basel for more than 14 years and has more than 22 years of Regulatory and CRO experience in India.
Mr. Viraj Shah is the co-founder and Director of Raptim. He is a post-graduate in Business Administration from the University of Richmond, US.
Mr. Shah has 25+ years of experience in Global Equity Finance and Management in USA & UK, and 15+ years of experience in the CRO industry.
Dr. Chirag has rich experience of more than 23 years in multidisciplinary area of Product Development in Pharmaceutical, Biotech companies and in Clinical Research Organisation (CRO).
His proven prowess lies in setting up global operations and scaling them up into profitable & sustainable businesses. Apart from that, global project management (Discovery & Clinical), Preclinical drug development, Due Diligence for Acquisition, Regulatory affairs, Medical Services, Pharmalicensing, Financial Management, System development, Marketing & Business Development.
Currently, he is playing key role in Strategic operation activities for the growth & alignment in all areas for Raptim.
During his career span, overseen the development of more than 20 Biosimilars, NCEs, 505b(2) and several ANDAs from Lab to Market. Also successfully managed global regulatory audits and product approval in global markets. He has several publications in peer-reviewed journals, delivered lectures in Professional associations, Academia and Community.
Prior to joining Raptim, he has worked with leading Indian companies and CROs.
Dr. Chirag Shah is PhD in Pharmacy from Saurashtra University, India. He is also specialized in the Pharmaceutical Management (PGDPM) with special focus on Marketing, Operation and Finance.
He is an associate member of American College of Clinical Pharmacology (ACCP), American Society of Clinical Oncology (ASCO), Life member of Indian Pharmacological Society (IPS), Indian Society of Clinical Research (ISCR) and Drug Information Association (DIA).
Dr. Milind Bagul is working as Head-Analytical Services. He is a PhD in Pharmaceutical Science. He has over 15 years of experience in managing Biopharmaceutical Studies and is associated with Raptim for more than 12 years. He has hands-on experience with different molecules using LC/MS-MS, In-Vitro Release Testing (IVRT), In-Vitro Permeability Testing (IVPT), and Biopharmaceutics Classification System (BCS) Biowaiver approach along with other dermatology and In-vitro binding studies.
He is overall responsible for the entire analytical work carried out in the lab, In-vitro study management, Project allocation and management, Client co-ordination Laboratory supervision, and Implementation of Good laboratory practices within the department.
During his tenure, he handled regulatory queries and support in inspection from the US, Europe, India, and WHO for analytical projects.
Mrs. Usha Ramakrishnan, working as Head-Quality Assurance, is a graduate in Pharmacy and Diploma in Industrial and Analytical Chemistry. She has extensive experience of about 32 years in Quality Assurance with various pharmaceutical companies and Contract Research Organizations (CROs). During her tenure, she has conducted many audit programs for the execution of a good Quality Management System in the organization. She facilitated various regulatory inspections and their queries like USFDA, MHRA, WHO, Brazil, MCC, BfArM (Germany) and HPRA (Ireland), NABL (ISO 15189-2012), CAP and DCGI.