For decades, the global pharmaceutical supply chain has been optimized for cost. But in recent years—and especially in the wake of geopolitical tension, COVID-era shortages, and increasing regulatory scrutiny—a new calculus is emerging: supply chain resilience is now a national security imperative.
Governments are responding. The United States, through multiple executive orders and policy frameworks, has begun offering incentives, procurement preferences, and regulatory pathways to bring pharmaceutical manufacturing—especially API and critical dosage form production—back home.
But while the vision is patriotic and the policy momentum is growing, the path to execution is complex, and it carries real operational risk.
That’s where QxP comes in.
The Realities of Onshoring: More Than Steel and Concrete
Bringing manufacturing stateside isn’t as simple as building new facilities. The true challenge lies in building systems that meet global regulatory expectations while standing up supply chains, validating processes, and training a capable workforce—all in parallel.
At QxP, we’ve worked with organizations navigating this journey. Whether it’s repurposing a legacy facility, transferring tech from overseas CMOs, or designing quality systems for a greenfield site, we understand the hidden friction points that can delay launches and increase compliance risk.
From Vision to Validation: QxP’s Risk-Informed Approach
Onshoring is a transformation—strategic, operational, and cultural. We help clients execute this transformation through:
- QxP-Focused Tech Transfers: We ensure successful technology transfer by embedding quality, compliance, and performance metrics at each stage—from sending site evaluation to method transfer and process robustness.
- Quality System Design & Readiness: Whether standing up a new QA organization or harmonizing global SOPs, we tailor regulatory-aligned systems built to scale and stand up to inspection.
- Workforce Development with Virtuosi: You can’t build compliant capacity without a trained team. Our immersive Virtuosi training platform (now IACET-accredited) enables hands-on GMP and aseptic skills development at scale—critical for new domestic sites that must ramp up rapidly.
- Regulatory & Risk Intelligence: We help clients navigate the patchwork of local, federal, and international expectations—while proactively identifying gaps in data integrity, process validation, and documentation practices.
Getting Ahead of the Curve
Onshoring may be driven by national priorities, but its success will depend on operational maturity and regulatory foresight. The winners in this transformation won’t be those who build the biggest facilities—but those who build robust, inspectable, and repeatable systems.
If your organization is contemplating—or actively pursuing—onshoring strategies for drug substance or drug product manufacturing, now is the time to partner with a team that’s done it before.
Let’s build something resilient, together.
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.
