In May 2025, the White House issued a sweeping Executive Order designed to accelerate the onshoring of essential medicine manufacturing. It calls on FDA and EPA to streamline regulatory pathways, incentivizes domestic production of active pharmaceutical ingredients (APIs), and underscores what many in the industry already know:
Our reliance on foreign drug manufacturing is no longer just a supply chain issue—it’s a national security threat.
But as the headlines circulate and political will mounts, a critical question remains unanswered:
How do you execute an onshoring strategy—compliantly, eficiently, and without costly missteps?
At QxP, we’ve been preparing for this moment.
Policy Momentum Is Not a Plan
Government funding and executive action can clear the path—but they don’t build quality systems, transfer tech, or train teams. That’s where the real work begins. And for companies trying to pivot toward U.S.-based production, the early decisions you make will define everything:
- Will your tech transfer hold up to FDA scrutiny?
- Will your workforce be audit-ready by your validation timeline?
- Will your site avoid remediation before your first commercial batch?
These aren’t hypotheticals. These are the failure modes we’ve seen—and helped our clients prevent.
QxP: Your Bridge from Policy to Production
For over a decade, Quality Executive Partners (QxP) has helped the world’s most trusted life sciences organizations meet complex regulatory and
operational challenges. Today, we’re applying that same rigor to onshoring initiatives across the U.S.
Whether you’re expanding a domestic site, building greenfield capacity, or transitioning from an overseas partner, QxP offers the specialized
expertise to make your investment count:
- GMP-Driven Tech Transfer: Structured, inspection-ready protocols with a focus on knowledge continuity, not just paperwork
- Quality System Buildouts: Fit-for-purpose, globally aligned quality infrastructure tailored to site size and product type
- Workforce Development at Scale: Our IACET-accredited Virtuosi® platform delivers immersive training that bridges the gap between education and cleanroom reality
- Regulatory Strategy & Submission Support: From QbD through validation and filing, we ensure your operational plans align with current expectations
Why Now?
The opportunity window is open—but it won’t stay open forever. Federal incentives are strongest for those who move early. Competitive advantage will go to the companies that integrate operational readiness with strategic foresight.
Don’t just onshore. Outperform.
Let’s Build the Future of American Pharma—Together
If your company is navigating the complexities of onshoring, don’t go it alone. QxP offers the insight, systems, and training needed to turn a high-stakes mandate into long-term success.
Connect with us to schedule a strategic consultation
QxP | Quality Executive Partners
Raising the standard. Protecting the mission.
QxP Vice President Christine Feaster is a 20+ year veteran in pharma quality assurance. Prior to joining QxP, Christine was a vice president of U.S. Pharmacopeia.
