PN

Prabu Nambiar

Founder, Strategic Advisor, Board Member at Syner-G BioPharma Group

Prabu Nambiar has extensive experience in the pharmaceutical industry, with a focus on regulatory affairs and CMC (Chemistry, Manufacturing, and Controls) strategies. Prabu is the founder and CEO of Syner-G BioPharma Group, where they provide consulting services for pharmaceutical CMC and quality issues. Prabu has also served as the Interim Head of RA-CMC at AVEO Oncology and as the Vice President of Regulatory Affairs at Vertex Pharmaceuticals, where they led the RA-CMC department and worked on key projects such as Incivek and Ivacaftor. Prabu has also held positions at U.S. Pharmacopeia, Cubist Pharmaceuticals, Wyeth Pharmaceuticals, Sepracor, and Bristol-Myers Squibb. Prabu is a member of the Board of Advisors for the College of Science at Oregon State University and has served as the Chair of the RS Section at the American Association of Pharmaceutical Scientists (AAPS).

Prabu Nambiar's education history is as follows:

Prabu Nambiar completed a Bachelor of Science (BSc) and Master of Science (MSc) in Chemistry from the University of Madras between 1977 and 1982.

Prabu then pursued a Ph.D. in Organic Chemistry at Oregon State University from 1983 to 1988.

Following this, Prabu Nambiar obtained Post-Doctoral Training in Organic/Bio-organic Chemistry at Brown University from 1988 to 1991.

Later, in 2003 and 2004, they attended the Questrom School of Business at Boston University, where they obtained an Executive MBA in Business Administration and Management.

Additionally, Prabu Nambiar has a certification in Regulatory Affairs, specifically the Regulatory Affairs Certification (RAC), from the Regulatory Affairs Professionals Society (RAPS). However, the specific month and year of obtaining this certification are not provided.

Location

Boston, United States

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Syner-G BioPharma Group

Syner-G BioPharma Group provides in-depth expertise across the three key elements of Chemistry, Manufacturing, and Controls (CMC): Regulatory Services, Technical Development, and Quality/IT. We call this CMC 360™. We also provide medical writing services, with expertise in authoring a variety of regulatory documents across a wide range of therapeutic areas and in all phases of development. Our regulatory affairs services include the development and implementation of global regulatory strategic plans, regulatory agency meeting support, and electronic submissions to regulatory authorities around the world. We have the skill set and experience to guide your prime asset through any development challenges and along the ever-changing maze of regulatory filing pathways, to a position of full compliance, and high quality. Our expertise spans small molecules, peptides, oligonucleotides, biologics, monoclonal antibodies, antibody-drug conjugates, and cell and gene therapy products.


Employees

201-500

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