Jan 12, 2026
As we've discussed previously, the FDA’s Manufacturing PreCheck pilot is designed to strengthen domestic drug production by providing early, proactive regulatory feedback on pharmaceutical manufacturing facilities, and to speed up readiness before official product applications are submitted. Combined with tariff pressure and geopolitical uncertainty, it pushes companies to reevaluate their manufacturing location, partners, and long-term strategy.
Recent discussions around onshoring and the FDA’s PreCheck initiative are sharpening the focus on quality systems, inspection readiness, and supply chain resilience, with an emphasis on protecting intellectual property by keeping manufacturing closer to home. As a result, onshoring and domestic capacity are moving rapidly into active planning.
At Pharmefex, this has shaped how we approach CDMO partnerships, including relationships with U.S.-based manufacturers. Experience across large CMO programs shows how tariffs, logistics constraints, and shifting trade conditions can introduce delays and cost pressure. Bringing production closer to market provides a more stable foundation for execution and regulatory readiness.
Pharmefex focuses on exactly this space. We support teams in selecting and managing CDMOs, structuring development strategy, and preparing regulatory submissions such as INDs and BLAs.
Schedule an intro call at www.pharmefex.com to learn more.
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Industry perspective on FDA PreCheck and onshoring
Sources
FDA Manufacturing PreCheck Pilot Program
https://www.fda.gov/industry/fda-manufacturing-precheck-pilot-program
Advancing quality in drug products
https://www.pharmtech.com/view/advancing-quality-in-drug-products