Dr.Ghanashyam Nagoji Rao is Medical Graduate ( Seth GS Medical College and KEM Hospital, Mumbai) with 15 years of experience in Clinical-Regulatory Strategy (USFDA & EMA, EU Nationals and UK ), Clinical Development, Medical Review/Medical Monitoring, Regulatory Medical Writing, Bio-Equivalence & Pharmacokinetics studies with training on Medical Writing/ Medical review in UK & USA. Dr Ghanashyam has worked on Bio-Similar, Complex generics and Modified Generics Molecules Clinical Development. Also he has worked with top most Indian companies like Piramal Healthcare, Dr Reddys, USV and Cipla and GlaxoSmithKline (UK and US R&D centres) in early phase developments departments. He has extensive experience in preparation of regulatory strategies and scientific advice documents; as well have experience in global Pharmacovigilance requirements.