In Vitro Diagnostics
Industry
Your test is only as strong as the evidence behind it. We build the regulatory case that clears it, on both sides of the Atlantic.
Two Regulators Rewrote the Rules. Your Test Answers to Both.
A diagnostic that ships in the US and the EU now lives under two frameworks that moved in opposite directions at the same time. Winning one market does almost nothing to prepare you for the other. The strategy has to be built for both from the first draft.
A Framework in Motion.
The 2024 LDT rule was vacated in court and left unappealed, so laboratory-developed tests sit in an oversight gap while distributed kits face a bar that keeps rising. QMSR harmonization with ISO 13485 took effect in February 2026.
- 510(k), De Novo, and PMA routes chosen to the evidence, not by default
- Pre-Submission strategy that gets the review division on record early
- CLIA waiver strategy for point-of-care and near-patient testing
- QMSR readiness now that FDA inspects against 13485-based records
A Higher Bar, Enforced.
Under IVDR, roughly 80% of diagnostics now need a Notified Body where almost none did under the old directive. Class C application deadlines fall in 2026, EUDAMED use becomes mandatory, and Notified Body capacity stays tight.
- Rule-based classification (A through D) argued and documented
- Performance evaluation: scientific validity, analytical, and clinical
- Technical documentation built to survive Notified Body scrutiny
- EUDAMED registration and UDI assignment mapped to the deadlines
The same evidence has to satisfy both regulators, and neither will accept the other's file as-is. A performance study designed only for a 510(k) rarely carries the clinical evidence IVDR demands; an IVDR dossier rarely lands as a US submission. We plan the evidence once so it does double duty, instead of paying for it twice.
Every Diagnostic Modality, Not Just the Easy Ones.
The regulatory questions change sharply with the technology. A lateral-flow test and a next-generation sequencing panel share a category and almost nothing else. We work across the range, including the ones regulators are still figuring out.
NGS, PCR & Molecular Assays
High-complexity tests where the analytical validation, bioinformatics pipeline, and variant interpretation are as much of the review as the wet chemistry.
- Tumor profiling and hereditary panels
- Infectious disease and syndromic panels
- Bioinformatics pipeline validation
Companion & Complementary Diagnostics
Tests tied to a therapy, where the diagnostic review runs on the drug's clock and a contrasting agency, sponsor, and timeline all have to align.
- Contemporaneous CDx and drug approval
- Pharma partnership and bridging studies
- Label alignment across drug and test
Immunoassays, POC & Diagnostic Software
From rapid tests and clinical chemistry to the algorithms and AI now embedded in diagnostic software, where the classification itself is often the hardest question.
- Lateral-flow and rapid antigen tests
- Software as a medical device and AI/ML
- Self-testing and near-patient designs
When the Test and the Drug Have to Cross the Line Together.
A companion diagnostic is only worth what the therapy is worth, and only if both clear on the same day. That makes the diagnostic timeline hostage to the drug program, reviewed by a different center, on evidence generated inside someone else's trial. Our dedicated companion diagnostics regulatory strategy practice runs this co-development end to end.
The test names the patients the drug is for. Get it wrong, and the therapy's whole label is in question.
-
One timeline governing two submissions
We manage the diagnostic filing against the drug's regulatory calendar so approvals land together, not months apart, with the linkage documented for both review teams.
-
The bridging study caught before it bites
When the trial assay is not the launch assay, the concordance study is planned early, not discovered at pre-approval when there is no time left to run it.
-
One team fluent in both drug and device
We speak to the therapeutics side and the diagnostics side in the same room, so the sponsor and the test developer stop translating for each other, per how we handle drug-device programs.
The Full Regulatory Program, From Classification to Post-Market.
A diagnostic needs the same discipline a drug does, applied to evidence that is entirely its own. We run the program end to end, or step into the one workstream that is holding the launch up.
Take the whole regulatory program, or drop us into the single piece standing between you and a filing.
Classification & Regulatory Strategy
Where a test lands under both frameworks, and the route that gets it to market fastest without picking up evidence gaps that surface later.
FDA Submissions & Interactions
The full US filing, and the Pre-Submission meetings that get the review division's expectations on record before you build to them.
EU IVDR Technical Documentation
The dossier a Notified Body will actually accept, with the performance evaluation report that carries the scientific, analytical, and clinical evidence.
Analytical & Clinical Performance
The evidence engine underneath every submission: studies designed once to satisfy both regulators instead of generating two separate datasets.
Quality Systems & ISO 13485
A quality system built for how diagnostics are actually made, ready for FDA's harmonized QMSR and the Notified Body audit in the same breath.
Post-Market Surveillance & PMPF
The obligations that begin at approval, not end there: IVDR's ongoing performance follow-up and the vigilance reporting both markets require.
Class C IVDR deadlines and a shifting US framework don't wait for the strategy to catch up. The sooner the plan exists, the more of it you control.
Talk to an Expert TodayBuilt Around the Evidence, Sequenced to the Deadlines.
A diagnostic program has a critical path, and it usually runs through the performance data. We find it first, then work backward from the market dates that actually matter.
Map Both Markets
A working session on intended use, technology, and target markets, ending in the classification and route under each framework.
Regulatory strategy memo within days
Design the Evidence Once
Analytical and clinical study plans built to serve both submissions, so the data is generated a single time and used twice.
Pre-Sub and Notified Body questions front-loaded
Build the Submissions
FDA filing and IVDR technical documentation authored in parallel, sharing a common evidence core and diverging only where they must.
Deficiency and AI responses handled as they land
Carry It Past Approval
The quality system, post-market plan, and vigilance processes stood up so clearance is a milestone, not a cliff.
PMS and PMPF live from day one on market
People Who Have Cleared Diagnostics, Not Read About It.
Diagnostics reward specifics. Knowing which analytical claims a review division will challenge, how a Notified Body reads a performance evaluation, and where a companion diagnostic timeline slips is the difference between a plan and a guess. Our people have run these filings and defended them, on both sides of the Atlantic, which is why the strategy holds up when the questions start.
-
Both frameworks, one team
FDA and IVDR strategy from the same people, so the US and EU programs are built to reinforce each other instead of contradicting on the record.
-
Senior from the first call
The people who scope your program are the ones who run it. No handoff to juniors once the engagement starts, per how we work.
-
Fluent in the drug side too
For companion diagnostics, we speak the therapeutic sponsor's language as well as the test developer's, so co-development stops losing weeks in translation.
Bring Us the Assay. We'll Bring the Pathway.
Whether you are staring at a Class C IVDR deadline, choosing between a 510(k) and a De Novo, or lining up a companion diagnostic behind a drug program, the first conversation is the same: thirty minutes, under NDA, and a straight read on where your evidence actually stands.
We typically respond within one business day.