Regulatory · Clinical · Site intelligence
From regulatory strategy to FDA clearance.
Intune Bio brings FDA regulatory affairs, clinical study services and data-driven site selection under one team. Diagnostics and medical device companies get a single plan, and fewer surprises at every stage.
Three practices. Use one, or all three together.
Each practice stands on its own. Together, regulatory strategy shapes study design, and study design shapes which sites you pick.
Regulatory Affairs
FDA pathway strategy, pre-submissions, 510(k), De Novo, CLIA Waiver and OTC filings for IVDs and devices.
Regulatory services →Clinical Services (CRO)
Analytical and clinical studies, designed to the protocols FDA expects and managed to budget.
Clinical services →Site Selection Intelligence
Independent, explainable scoring of clinical sites, so you start with sites that activate fast and enroll.
Site intelligence →Regulatory Affairs
A clear path to FDA, before you spend on studies
We start with the pathway, the predicate and the questions FDA will ask, so every study you run is one you actually need.
Discuss your submissionClinical Services
Studies that hold up to FDA review, on budget
We design and run the analytical and clinical work your submission depends on, and we benchmark so you don’t overpay for it.
Plan your studySite Selection Intelligence
Feasibility is self-reported optimism. Enrollment isn’t.
The Intune InSite Score is built from independent verification of what sites have actually done by cross-referencing trial registries and multiple data sources, not from what the sites claim they can do.
Each signal is weighted against your protocol and compared with similar sites and studies, so every site is measured the same way. Every score comes with its reasons and the risks to watch.
- Validate a shortlist before the study: ranked, explained and risk-flagged
- Rescue a delayed study: triage which sites can recover
- 185,000+ research centers in coverage
Why Intune Bio
Fewer handoffs between strategy, studies and sites
Strategy drives the studies
Study scope follows from the regulatory plan, so you don’t pay for data FDA won’t ask for.
Sites chosen on evidence
Clinical sites are picked with the same scoring we offer sponsors and CROs, not from a favorites list.
Independent benchmarks
We compare consultants, CROs and labs stage by stage, so your budget reflects the market.
Scoped by stage
Proposals are priced per stage with clear decision points, so you commit one step at a time.
How we work with you
Discovery call
Your product, your stage and where you need help: regulatory, clinical, sites, or all three.
Scoped proposal
A plan priced stage by stage, with the decision points and benchmarks behind it.
Execution
We run the work with regular updates, and review each stage before the next begins.
Submission & beyond
Filing, FDA questions and, for ongoing studies, site rescue if enrollment slips.
Questions clients ask us
Do I have to use all three services?
No. Many clients start with one, such as a regulatory strategy or a site shortlist, and add others as the program moves forward.
Which products do you support on the regulatory side?
Our regulatory work focuses on in vitro diagnostics and medical devices, including 510(k), De Novo, CLIA Waiver and OTC submissions.
Do you run studies yourselves or through partners?
We design and manage studies and work with qualified CROs, labs and clinical sites, chosen on evidence and benchmarked on cost.
Is site selection intelligence only for diagnostics?
No. It covers Phase I–IV therapeutics, vaccines, diagnostics and devices, including multi-region programs.
Does Intune replace our CRO?
No. We work alongside CROs, adding regulatory direction, independent site scoring and cost benchmarks.
What data do you need to score sites?
Non-confidential study inputs such as protocol parameters, regions and proposed sites. We do not request or store patient-level data.
Tell us where you are
Planning a submission, scoping a study or choosing sites? Send a few details and we’ll reply within one business day with next steps.
Prefer email? customercare@intune.bio
Intune Bio · 2265 E Foothill Blvd, Pasadena, CA 91107, USA