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.

• Examining FDA's New Quality Agreement Guidance

  3/10/2017

  FDA’s new guidance for industry Contract Manufacturing Arrangements for Drugs: Quality Agreements specifically addresses seven elements that should be included in a quality agreement: quality unit activities, facilities and equipment, materials management, product-specific considerations, laboratory controls, documentation, and change control.

• FDA's New Quality Agreement Guidance — What It Says (And What It Fails To Say)

  2/1/2017

  In November 2016, the FDA issued new guidance for industry titled Contract Manufacturing Arrangements for Drugs: Quality Agreements. This guidance is timely, given the rise of the virtual biotech company in the development landscape. Most development programs now include the support of at least one contract service provider (CSP) for services that vary from early development contract research to commercial manufacturing and analytical support.