Deepa Arora (MBBS, MD) is a physician with more than 20 years of experience and demonstrated history of successfully delivering in the Clinical Development, Pharmacovigilance, Post Authorization Safety Studies and medico-regulatory writing with the Pharmaceutical industry.
She worked in Indian MNCs (Lupin, Wockhardt and Dabur Research Foundation) and CROs. She has in-depth understanding of clinical trial regulations of India and the clinical development of NCEs, biosimilars, hybrid/ 505b(2) products and orphan drugs along with the experience in successfully planning and handling complex meetings with regulators, including experience of interacting with global regulators for pre-IND meetings, meetings for referrals with CHMP & scientific advisory meetings with US FDA, MHRA, EMA, DCGI as clinical development & safety expert.
Under AICROS, she is responsible for research activities and conducting clinical trials in India, Nepal and Bangladesh. She is the Director of a CRO based in India since 2019, where she is collaborating with start-ups, small to mid-size biopharmaceutical and medical device companies to support the clinical development of their products and ensuring compliance with global pharmacovigilance regulations.