Articles by Bikash Chatterjee
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FDA's New Quality Agreement Guidance: What It Says (And What It Fails To Say)
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.
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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.
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Effective Risk Management: A Catalyst For Quality Performance
6/8/2016
When we think of risk in the context of drug development and manufacturing, it is human nature to associate any risk-based approach with adding risk to the decision or process. This guidance laid the foundation for two important concepts that influence how we develop and guarantee the quality of our drug products today.
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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.