News & Insights

Establishing a new pharmaceutical manufacturing site in the US has always been a high-stakes investment: capital-intensive, complex, and often constrained by a regulatory timeline that comes too late in the game. For teams trying to move fast without compromising compliance, that lag creates uncertainty.

But that may be about to change.

The FDA’s proposed PreCheck program signals a shift toward earlier engagement, offering design and construction teams the opportunity to integrate compliance from the start. Here’s what it could mean for project sponsors, and how Salas O’Brien is already preparing to help clients seize the opportunity.

What is FDA PreCheck? A quick primer

FDA PreCheck is a proposed two-phase review pathway designed to speed up the development and approval of pharmaceutical manufacturing facilities in the US. Right now, FDA inspections usually happen late in the process, once the facility is built and tied to a specific product. PreCheck flips that model through two phases by involving the FDA much earlier.  In the proposed first phase the FDA will support early facility design and construction with technical advice and increased regulatory interactions.  The second phase involves early chemistry/manufacturing/controls (CMC) feedback.

The biggest ask from companies at the FDA public meeting? Facility review to be decoupled from pre-approval inspections and authorization applications.   Under the current process, if the site isn’t ready, the product doesn’t move forward. Attendees at the FDA  PreCheck meeting proposed solutions to get the building evaluated on its own, ahead of any product submission.

For project teams, earlier interaction with the FDA  means  regulatory clarity and fewer last-minute surprises. Pharmaceutical manufacturers know the pain of the millions of dollars in lost revenue when a late-change project delays the schedule. Instead of retrofitting compliance at the end, teams can align design decisions with FDA expectations from the start, saving both time and money. For Salas O’Brien, this aligns well with our “validation-forward engineering” strategy.

What’s changing (and why it matters)

FDA PreCheck is still in draft form, but the direction is clear: the agency is moving toward earlier, more structured engagement with project teams during design and construction.

If implemented, PreCheck would give companies the opportunity to request FDA input on:

• Facility layout and cleanroom classification
• Material, personnel, and waste flows
• Utility zoning and HVAC strategy
• Quality systems, including early CMC considerations

The proposed framework would also introduce a new use of the Type V Drug Master File. The hope is that for the first time, facility design could be reviewed independently of any specific product. That’s a significant change from current practice, where facility inspection is tied directly to the product submission and comes late in the approval timeline.

The benefit? Risk reduction. Faster commercialization timelines.

Facility issues that typically surface during a pre-approval inspection — sometimes months after construction is complete — could be addressed much earlier. As one industry leader described it, “You’re going to be able to solve facility issues months, even years before they occur.”

While the program is not yet final, pharma companies investing in new domestic capacity should begin considering how this shift might affect design decisions, project phasing, and validation strategy. Salas O’Brien is already aligning internal teams to support this forward-looking model of facility planning.

Strategic opportunities for Salas O’Brien clients

As FDA PreCheck moves toward implementation, it presents a practical opportunity for clients to strengthen the connection between facility design and regulatory outcomes.

Salas O’Brien projects would be eligible for FDA review during the design phase. This early interaction gives teams the chance to align facility layouts, material flow, utilities and cleanroom zoning with FDA expectations before construction begins.

This alignment creates a more predictable regulatory path. By addressing compliance considerations early, project teams reduce the risk of delays later in the approval process. It also opens the possibility of faster product readiness, since fewer facility-related issues are likely to emerge during final inspections.

For clients competing to bring products to market on compressed timelines, these changes make facility design a more strategic asset. Salas O’Brien’s validation-informed approach positions projects to meet both operational and regulatory goals without unnecessary rework that can slow the timeline.

Risks, unknowns, and what to watch

While FDA PreCheck presents real opportunities, there are still open questions that project teams should factor into early planning:

• Timeline unconfirmed. The timeline for formal implementation hasn’t been announced. Guidance is still in development, and it’s not yet clear when or how the program will be rolled out.
• Impact on documentation. Participation may also raise the bar for design documentation. Teams could be expected to share more detail earlier in the process, especially if they want meaningful feedback from the FDA during the design phase.
• Need for higher coordination. Early FDA engagement adds a new layer of communication between the regulator, the client, and the design team. Making that work smoothly will require alignment across disciplines, including quality, engineering, and project management.

These shifts won’t affect every project immediately, but for clients building new domestic capacity or planning long-range capital investments, they’re worth tracking now.

How to prepare: Salas O’Brien’s perspective

The FDA PreCheck has not yet been finalized, but the shift toward earlier engagement is already influencing how forward-looking teams plan projects. For Salas O’Brien clients, this is a good time to reassess when and how regulatory strategy shows up in the design process.

Plan for earlier technical alignment

Basic design is no longer the early stage. By the time preliminary layouts are developed, teams may already be in a position to engage with the FDA. This calls for tighter coordination between facility planners, quality leaders, and capital teams from the start.

Use early design reviews as rehearsal

Design reviews should serve a dual purpose, both for internal alignment and preparation for FDA interaction. Treat them as opportunities to validate assumptions, clarify flows, and stress-test GMP strategies before formal documentation begins.

Treat compliance feedback as iterative

Engaging the FDA earlier means receiving input earlier. Teams should expect to revisit and refine designs more than once. Building in time and budget for that iteration will reduce pressure later in the process.

How Salas O’Brien can help

The FDA PreCheck program introduces earlier regulatory involvement that affects both project timelines and how teams plan facility design. Early engagement means early risk reduction. For pharma companies investing in domestic capacity, this is a moment to reframe how compliance fits into capital planning.

Our cross-discipline teams—including CQV—can support client conversations with the FDA. Our workflows bring together engineering and validation planning so you can make informed decisions that support readiness.

Reach out to us to discuss your project at [email protected], or connect with one of our contributors below.

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