Articles by Bikash Chatterjee

  1. Achieving Annex 1 Compliance In Sterile Manufacturing, Part 3: Building A Compliant Program 7/7/2026

    In this third and final article of this series, let's take a closer look at what a well-constructed Annex 1-compliant program looks like at each stage, from gap assessment through governance.

  2. Achieving Annex 1 Compliance In Sterile Manufacturing, Part 2: Objective Measurement Tools 6/30/2026

    Let's examine the objective measurement tools that directly address each of the gaps between Annex 1 expectations and what drug manufacturing facilities can currently demonstrate in practice.

  3. Achieving Annex 1 Compliance In Sterile Manufacturing, Part 1: Common Compliance Failures 6/23/2026

    A persistent gap remains between what Annex 1 requires and what facilities can demonstrate. Let's take a closer look at four common compliance failures.

  4. 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. 

  5. 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. 

  6. New FDA Draft Guidance: Qualification Process For Drug Development Tools 2/3/2020

    The FDA recently issued its draft guidance on the qualification process for drug development tools (DDTs), as part of the commitment mandated by the 21st Century Cures Act. The draft guidance provides a high-level description of the intent and content of the DDT program, but it does not address evidentiary standards or performance criteria for purposes of DDT qualification, leaving it to industry to propose the scientific argument and data package.

  7. Understanding The FDA's KASA Framework 10/30/2019

    The FDA's Knowledge-Aided Assessment & Structured Application Framework marks an ambitious step forward in standardizing and increasing the efficiency of the drug review process. Here's what it will take for the framework to succeed. 

  8. Opportunities And Risks In The Global Regulatory Environment 2/13/2014

    Todd and Todd interview Bikash Chatterjee, the President and Chief Technology Officer at Pharmatech Associates.  Bikash provides an excellent overview of the global regulatory environment, along with both the opportunities and risks for the pharmaceutical industry.  Additionally, he offers expert insights into effective cross-cultural business collaborations and highlights science and technology innovations that will be game-changing in the next five to ten years.