Advisory Body

Dr. Smita S. Singhania

Dr. Smita, a PhD in Microbiology brings with herself more than 23 years of rich experience in the pharmaceutical industry, which involved driving R&D initiatives, managing regulatory compliances, clinical research & intellectual property management. She was featured amongst the top 50 Biotech women professionals in India, by Biospectrum – a leading biotech business magazine of Asia in March 2013.

She has professional excellence in coordinating and managing product development in the field of vaccines, biological, pharmaceuticals – API and Formulations, encompassing CMC data, coordination of pre-clinical studies, clinical research operations and regulatory approvals to manufacture and market bio-pharmaceuticals. With the International regulatory clearances such as WHO prequalification, Dr. Smita has wide experience in drug regulations and facilitating requisite approvals.

Having wide experience in grant writing and mobilization of funds from the Government to the pharmaceutical industry, Dr. Smita has led several grants and soft loan projects of industry for funding from DST and DBT. She also played a key role in negotiation and technology transfer of JE Vaccine project from ICMR (NIV, Pune) to Bharat Biotech International Ltd.

Dr. Smita has generated International research collaboration with Mid Western Univ., IL, Univ. of Texas at San Antonio, Leeds Metropolitan Univ. UK, Awex- Wallonia’s Biotech Park, Belgium etc. with Symbiosis International University, India. : She is a co-inventor in international patents - on Rotavirus vaccine formulation, (the product is in the market now) and herbal water formulation with Bharat Biotech International Ltd. and Century Biologicals.

She is an acknowledged expert in drafting/filing/reviewing patents, Freedom to Operate Analysis.

Key Memberships and Contributions:

• Member Working party on Biotechnology, Nanotechnology and Converging Technology (BNCT), OECD, Paris.
• Life Science Council Member of Federation of Indian Chamber of Commerce and Industries (FICCI)
• WHO expert for development of influenza vaccine program 2010.

Dr. Smita has held senior leadership roles in academics and the corporate sector having worked with leading pharmaceutical as well as biotech companies and has been a consultant to multiple corporate houses. She has umpteen numbers of publications in various journals of repute to her credit and has participated in several national and international conferences.

Her interest areas include Regulatory Affairs, Clinical Research, preparation and filing of IND’s, NDA, Similar Biologics, Vaccines, Pharmaceuticals, Import, Registration and Marketing Authorization, Post Approval Changes filings, preparation of CTD and DMF, Intellectual Property Management, Patent Drafting etc. Government funding applications, Product Development as per regulatory requirements. Life cycle management of product from regulatory perspective, Project Management, Vendor Certification GMP Audits, Establishment of Quality Management System (QMS) and related documents, Scientific Writing and Documentation etc.

Presently, Dr. Smita is the CEO of SMIBIO Consultancy and is the Principal Adviser & Mentor at Nxt Directionz Consultancy.