For years, the U.S. pharmaceutical supply chain has been increasingly reliant on foreign manufacturing. This dependence became a stark reality during recent global events, highlighting a critical vulnerability in our national security and public health.
In response, the FDA has taken a significant step with its new PreCheck program.
Understanding PreCheck
Announced in early August 2025, the FDA PreCheck program is a two-phase initiative designed to streamline the regulatory process for new domestic pharmaceutical manufacturing facilities.
Phase one creates dialogue. Manufacturers engage in frequent communication with the FDA during facility design, construction, and pre-production. This early collaboration helps iron out potential issues before they become costly roadblocks.
Phase two accelerates approval. Pre-application meetings and early feedback on Chemistry, Manufacturing, and Controls sections of drug applications reduce delays and uncertainty.
There’s a long road ahead before PreCheck becomes a reality, but the FDA’s goal is clear: increase regulatory predictability and facilitate construction of new manufacturing sites in the United States. By providing a collaborative path forward, PreCheck incentivizes companies to invest in domestic production and reduce reliance on foreign suppliers.
The Missing Piece
However, streamlined regulations are only part of the equation. The design and construction of these highly complex facilities remains a significant challenge.
Pharmaceutical facilities aren’t ordinary buildings. They require clean rooms with validated HVAC systems, specialized workflows that prevent cross-contamination, and rigorous adherence to cGMP standards. Every decision – from material selection to traffic patterns – affects compliance and operational efficiency.
Traditional timelines don’t work anymore. In an industry where speed to market directly impacts both profitability and public health outcomes, choosing a delivery model that accelerates time to market has substantial benefits.
A Path Forward
The most successful domestic manufacturing projects share a common thread: they treat facility development as an integrated challenge rather than sequential phases.
Collaboration drives speed. When design and construction teams collaborate from day one, the design-build delivery model can reduce pharmaceutical facility build time by 30-50%, based on industry benchmarks and ARCO Design/Build’s project portfolio. This approach eliminates the friction and delays that occur when architects, engineers, and builders work in silos.
Compliance gets built in, not bolted on. Regulatory requirements inform every decision from concept through commissioning, preventing costly retrofits and validation delays.
This methodology becomes even more powerful when combined with PreCheck’s regulatory clarity. Companies can now achieve both regulatory and construction efficiency simultaneously – dramatically reducing the total time from planning to production.
The Opportunity
The pharmaceutical industry stands at an inflection point. The FDA has removed a major regulatory barrier. Construction methodologies exist that can deliver facilities at unprecedented speed. The companies that recognize and act on this convergence will lead the reshoring movement.
At ARCO Design/Build, we’ve seen firsthand how this combination transforms project outcomes. Our collaborative approach, developed over decades of life sciences construction, aligns perfectly with PreCheck’s collaborative framework. We understand that these facilities aren’t just buildings – they’re critical infrastructure for America’s health security.
The bottom line: The FDA’s PreCheck program provides the regulatory foundation for a more resilient pharmaceutical supply chain. Success now depends on execution. Companies that leverage both regulatory innovation and construction excellence will not only strengthen their own operations but contribute to a more secure pharmaceutical future for the United States.
Ready to explore how design-build can accelerate your domestic manufacturing plans? Contact ARCO to discuss your PreCheck strategy.
