Are You Ready for a CNPV Inspection on Day One?
How Sponsors Can Stay Ahead When Speed Meets Scrutiny
The FDA’s new Commissioner’s National Priority Voucher (CNPV) program is redefining what “fast-tracked” really means. For the first time, sponsors developing therapies that address urgent national priorities such as major public health crises, domestic manufacturing gaps, or critical unmet medical needs can receive an accelerated review timeline as short as 60 days.
That’s game-changing for patients and sponsors alike. But speed has a trade-off: compressed regulatory oversight. When review time is shortened, the expectation for inspection readiness doesn’t disappear it just shifts earlier.
When your submission window shrinks, your inspection window does too.
The Double-Edged Sword of Rolling Submissions
Rolling submissions are a cornerstone of many accelerated pathways, including CNPV. They allow sponsors to submit portions of their application, modules of the BLA or NDA, as they’re completed, rather than waiting until the entire dossier is ready.
This approach streamlines FDA engagement, but it also sends a powerful signal: “We’re ready.” And the moment that signal is sent, the clock for inspection readiness starts ticking.
Once rolling modules begin, regulators have more visibility into your data, operations, and clinical sites. The FDA can (and often will) initiate Good Clinical Practice (GCP) inspections not only of clinical sites, but of the sponsor organization itself, to verify oversight systems, data integrity, and documentation are inspection-ready from the outset.
A Real-World Example: The Inspection That Came Early
A few years ago, one of our clients was preparing a rolling submission under an accelerated program. They had managed a large, complex study with high enrollment and multiple CRO partners.
The FDA first visited their highest-enrolling site as a standard GCP inspection rather than as part of the BLA submission. But what came next was even more unexpected:
The agency inspected the sponsor on the very day the submission was filed.
That inspection wasn’t random. It was strategic. FDA investigators wanted to confirm that the sponsor’s oversight framework, TMF completeness, and data verification processes were already operating at submission quality not being finalized post-submission.
It was a powerful reminder that in today’s regulatory climate, inspection readiness must exist before submission, not after.
The New Reality: Inspections Without Warning
Under accelerated review programs like CNPV, inspections can occur at any point before, during, or immediately after submission. For sponsors used to traditional timelines, this creates a high-stakes environment where “good enough” preparation is no longer sufficient.
Sponsors often assume they’ll have time post-submission to tidy up TMFs, resolve outstanding audit findings, or finalize CAPAs. Under a 60-day review window, that margin disappears.
Here’s where we see sponsors most at risk:
- Incomplete eTMFs: Documents missing, unfiled, or not QC-verified.
- Oversight gaps: CROs and vendors operating without cohesive documentation or traceability.
- Data integrity vulnerabilities: Inconsistent source verification or unresolved queries.
- Open CAPAs: Corrective actions still pending at submission.
In an accelerated pathway, these aren’t just operational challenges — they’re regulatory risks. And in some cases, they can delay or derail approval altogether.
How to Prepare: Building Inspection Readiness into the Development Timeline
Start early — finish strong.
Sponsors pursuing CNPV designation should build inspection readiness into their operational DNA long before submission. Here’s how:
- Conduct a proactive inspection readiness assessment.
Do it at least six months before submission. Evaluate not only the TMF but the broader ecosystem of oversight, including data management, data architecture & lifecycle, vendor accountability, and safety documentation. - Audit eTMF health.
Confirm completeness, accuracy, and QC status. Pay special attention to metadata, version history, and audit trails. A missing document or unverified record can draw unnecessary scrutiny. - Validate oversight accountability.
Inspectors want to see that sponsors maintain oversight — not delegate it. Ensure CRO and vendor roles are clearly defined, tracked, and documented. - Simulate a sponsor inspection.
Conduct a mock inspection at the sponsor level. Can your team produce oversight documentation, communications, and decision logs on demand? The best time to find gaps is before FDA does. - Leverage GenAI for compliance intelligence.
AI-enabled quality monitoring can identify missing TMF artifacts, flag inconsistent data, and track CAPA closure trends in real time — a valuable edge when the timeline tightens.
Partnering for Confidence Under Pressure
At Just in Time GCP, we’ve guided sponsors through the full spectrum of accelerated programs from rolling submissions to same-day inspections. Our team knows what “inspection-ready” really means in the era of compressed regulatory review.
We specialize in:
- Pre-approval and sponsor inspection readiness
- eTMF and data integrity reviews aligned with FDA and EMA expectations
- Oversight documentation assessments for CROs and vendors
- GenAI-driven signal detection that surfaces issues before inspectors do
Our mission is simple: to help sponsors enter accelerated programs with confidence, not anxiety. Because when the review window narrows, preparation is everything.
The Takeaway
If you’re preparing to apply for a CNPV, don’t wait until Day 1 to think about inspection readiness because the inspection might be on Day 1.
The new regulatory reality demands that sponsors think differently about quality, oversight, and readiness. The faster the pathway, the earlier the preparation must begin.
Authored by
Donna Dorozinsky, Founder & CEO, Just in Time GCP
