ARTICLES BY BIKASH CHATTERJEE

CMC And Quality Considerations When Engaging Your CDMO
3/1/2022

Before pursuing an outsourcing strategy, it is essential to define what processes will be kept in-house and where your CDMO partner will take the lead.
Navigating The FDA's Emergency Use Authorization Process
5/14/2020

The FDA has been authorized to grant Emergency Use Authorizations for SARS-CoV-2. This will impact both internal manufacturing and the CDMOs that drug sponsors employ.
Business Continuity & The Coronavirus: Are Your Pharma Operations At Risk?
3/4/2020

In the face of a pandemic, the value of a robust business continuity plan cannot be overstated. Organizations should actively evaluate those plans, focusing on service providers and partners.
Analytical Testing Strategies For Clinical And Commercial Operations
3/1/2019

A summary of a survey designed to better understand the factors considered when establishing an analytical-testing strategy for clinical-material release.

Bikash Chatterjee

Bikash Chatterjee is CEO of Pharmatech Associates. He has over 30 years’ experience in the design and development of pharmaceutical, biotech, medical device, and IVD products. His work has guided the successful approval and commercialization of over a dozen new products in the U.S. and Europe. Chatterjee is a member of the USP National Advisory Board and is the past chairman of the Golden Gate Chapter of the American Society of Quality. He is the author of Applying Lean Six Sigma in the Pharmaceutical Industry and is a keynote speaker at international conferences. Chatterjee holds a B.A. in biochemistry and a B.S. in chemical engineering from the University of California at San Diego.