A Decade of Science, Judged in Ten Months. Filing Is a Craft.
NDA strategy and execution — route selection under Section 505, the PDUFA clock managed deliberately, and a dossier the review division can navigate without asking where anything is.
Three Doors Into the US Drug Market. The Statute Prices Each One.
The route decides what evidence you must generate, what you may borrow, and what exclusivity you can earn or must design around.
The Full Application
Every investigation your own — the route for new molecular entities, priced in pivotal trials and years. The reward is the strongest label and up to five years of NCE exclusivity.
The Bridge Application
A full NDA that leans on evidence you did not generate — published literature, FDA’s prior findings for a listed drug — bridged to your product by targeted studies. New dosage forms, routes, combinations, and repurposed molecules live here.
The Generic (ANDA)
Duplicate of a reference drug — bioequivalence instead of clinical trials. Not an NDA at all, but the door your lifecycle strategy must account for, because it opens onto your molecule eventually.
The PDUFA Clock Is Managed, Not Merely Survived.
An NDA is first judged on whether it can be reviewed at all: FDA has 60 days to file or refuse-to-file it. Then the PDUFA goal date — ten months from filing for a standard review, six for priority — becomes the program’s organizing fact. Information requests, the mid-cycle communication, advisory committee scheduling, labeling negotiation, and the pre-approval inspection all land inside that window, each capable of consuming it.
A major amendment — substantial new data during review — can extend the goal date by three months. Which is the polite way of saying: what you file on day one decides whether the clock is yours or the deficiency letter’s.
More applications stumble on CMC than on efficacy — process validation, specifications, and the pre-approval inspection are the unglamorous critical path.
The Numbers an NDA Program Plans Around.
Every workstream in the filing year backs out from these.
The filing decision. A refuse-to-file is public inside your company even when it is private outside it — and it resets everything.
The PDUFA goal after filing: ten for standard review, six for priority — the difference a priority review voucher or designation buys.
What a major amendment costs: substantial data submitted mid-review moves the goal date — the argument for filing complete, not filing early.
Six Disciplines That Carry an NDA.
Strategy first, then the execution details that decide whether strategy survives.
505 Route Strategy
The (b)(1) versus (b)(2) decision made on evidence you can borrow, exclusivities in play, and patent certifications you can defend — before the clinical plan hardens around the wrong one.
Pre-NDA Meeting & Filing Readiness
The pre-NDA meeting run to close filing-risk questions, and a refuse-to-file self-audit performed like the review division will — because they will.
Dossier Architecture
Modules 1–5 built as one navigable argument: summaries that actually summarize, data that reconciles, hyperlinks a reviewer can trust at 11 p.m.
Module 3 & PAI Readiness
Process validation, specifications, and facility readiness converging on the goal date — the pre-approval inspection treated as part of the application.
Review-Cycle Management
Information requests answered in days, the mid-cycle read soberly, advisory committee prep when the science draws a public hearing.
Labeling Negotiation
The label negotiated in the review’s final weeks is the product you will actually sell — we argue it from the data, clause by clause.
Borrowed evidence still has to be bridged, and every borrowed finding drags a patent certification behind it.
505(b)(2) Is a Shortcut Only if the Bridge Holds.
The (b)(2) route can cut years from development — and it is also where sponsors most reliably underestimate the work. The scientific bridge (usually comparative bioavailability, sometimes more) has to make the borrowed findings yours; the patent certifications against the listed drug can trigger a 30-month litigation stay; and the label you want has to survive both.
We treat every (b)(2) as three deliverables — the bridge, the certification strategy, and the label — scoped together at the start, because discovering their interactions in review is how a two-year program becomes a four-year one. The full analysis lives on our 505(b)(2) pathway page.
Six Failure Modes We Are Brought In to Prevent.
Filing-year failures are mostly integration failures — the parts were fine.
Filed early instead of complete
A dossier submitted to hit a board date with known gaps — converted by the review into a refuse-to-file or a major-amendment extension.
Summaries that don’t summarize
Module 2 written as a pointer farm — forcing reviewers into raw data and turning every question into an information request.
The site that wasn’t ready
A pre-approval inspection scheduled by FDA, not by your validation timeline — and a complete response letter that has nothing to do with your science.
Datasets that don’t reconcile
Numbers that differ between the CSR, the ISS, and the label — each discrepancy a credibility tax on everything else in the file.
The (b)(2) bridge assumed
Borrowed findings cited without the comparative data that connects them to your product — the deficiency that arrives at month nine.
Labeling started at approval
The negotiation entered without a target label and fallback positions — conceding in days what the data earned over a decade.
NDA Leadership for the Filing Year and the Review That Follows.
Our leads have run route strategy, filing-readiness audits, and review cycles — on their own programs, not from the sidelines.
“The review division reads a thousand pages a week. The applications that win are the ones that respect that — one argument, told once, reconciled everywhere.”
The discipline we bring to marketing applications.
Entering the Filing Year? Decide the Route and Audit the File Before FDA Does.
A senior regulatory lead can pressure-test your 505 strategy and filing readiness while the fixes are still yours to schedule.
Senior-led. Embedded in your team. No junior hand-offs.