Newsletter | July 22, 2025

07.22.25 -- Strategic Considerations For Generic GLP-1 Combination Product Development

A Risk-Reduction Framework For Generic GLP-1 Combination Products

Discover how early-stage device planning—featuring task analysis, physical comparisons, and human factors studies—can help pharma partners reduce regulatory risk and strengthen ANDA submissions.

De-Risking ANDA Submissions For Generic Semaglutide Combination Products

Explore how a drug device developer’s pre-ANDA strategy consisting of task analysis, physical comparisons, and formative comparative use human factors studies can help support successful ANDA submissions.

Proactive Pre-Submission Strategies To Mitigate Risk In Generic GLP-1 ANDAs

Learn how a drug device developer is helping pharma partners de-risk and navigate their ANDA submission with greater confidence through early-stage comparative analysis and formative human factors studies.

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