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Sponsored Design Multi-Agent AI Systems Using MCP and A2A: Engineer your own Pyt Design Multi-Agent AI Systems Using MCP and A2A: Engineer your own Pyt

Author

Zuki Patel

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2 papers indexed here

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Open access Sep 2026

Decoding FDA Complete Response Letters: Regulatory Challenges and Strategies for Successful Drug Approval

A Complete Response Letter (CRL) is provided by the U.S. Food and Drug Administration (FDA) when a marketing application is deemed unprovable in its existing format. Although CRLs hold important regulatory implications, there is a lack of comprehensive analytical frameworks for their assessment.  To develop a systemati...

Mukti Kapdi, M. Zaveri, Zuki Patel et al. · 0 citations
Open access Sep 2026

Regulatory Trends and Challenges in Pharmaceutical Submissions: A Critical Analysis of Health Authority Requirements on Nitrosamine Impurities, Elemental Impurities, Forced Degradation and Genotoxicity

Comparing regulatory anticipations of impurity management within pharmaceutical submissions in terms of elements of nitrosamine impurities, genotoxic impurities, forced degradation, and elemental impurities shows that the compliance with harmonized ICH requirements and regulatory frameworks allows managing impurities r...

Darshan Mistry, Zuki Patel, Vinit Movaliya et al. · 0 citations

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