Our Experts

Dr.Ghanashyam Nagoji Rao

Chief Clinical Development Expert and Co-Founder

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.

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Dr. Shalini Singh

Business development Manager

Dr. Shalini Singh working as a Business development Manager, takes care of the business development activities in Europe. She is very passionate about pharmaceutical, Healthcare and Lifesciences activities. Having a good acumen of the medical writing documents, she understands the client requirements and is very keen in providing focused and customer centric solutions for their business need. Dr. Shalini did her Bachelors in dentistry ( B.D.S) from Sri Ramchandra Dental College, Sri Ramchandra University, Chennai ( Tamilnadu) and Post Graduate diploma in Clinical Research and Pharmacovigilance from ICRI, Delhi.

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Parminder Kaur

Chief Regulatory Expert and EU QPPV, Co-Founder.

Parminder is the founder of RegPak BioPharma Consulting based in Amsterdam providing regulatory and pharmacovigilance services to many National and International companies. She has played a major role in setting the in-house RA and PV systems in compliance with the European regulations at various companies; Assisted various companies during Inspections and Audits conducted by EU Regulatory Authorities. Parminder was awarded Sikh Business Women of the year award in 2014. In 2011, she led an IMI Project on combination therapy at EFPIA, in close collaboration with Research & Development Group (RDG) at European Commission. In March 2007, Mrs. Kaur had been selected by the European Federation of Pharmaceutical Industries and Association (EFPIA) for her global expertise and also had an honour to be the Scientific Representative from India for the year 2000-2001, duly sponsored by UNESCO. Parminder had been a speaker, panellist and Masterclass provider at various international conferences.

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