ARTICLES BY BIKASH CHATTERJEE
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CMC And Quality Considerations When Engaging Your CDMO3/21/2022
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.
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FDA’s 2021 Focus Areas Of Regulatory Science: 5 Trends To Watch3/19/2021
Examine key elements from the report “Advancing Regulatory Science at FDA: FARS” that provide meaningful regulatory insight on new and emerging approaches to drug development and governance.
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FDA Steps Up Support For Advanced Manufacturing Technologies2/22/2021
Examine the potential of the FDA and NIST's MOU to provide critical technical guidance that could greatly standardize the approaches to implementing AMTs, such as those used in continuous manufacturing.
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Pharma 4.0: A New Framework & Process For Digital Quality Management11/6/2017
Contrary to how it sounds, controlling information is not about withholding key documents or facts that are relevant to the CMO bidding process to see how the bidders react, or only supplying pertinent information if requested. In fact, it is exactly the opposite is true.