Regulatory diligence for funds and family offices, not just for ourselves.
VC, PE, and family office investors evaluating a healthcare or medtech target rarely have in-house reviewer-side expertise. We provide that assessment directly, either for a single deal or on a standing basis across a fund's pipeline.
- Regulatory and scientific diligence for a specific transaction
A focused assessment of a target's regulatory pathway, classification, predicate strength, submission readiness, and the scientific evidence behind its claims, delivered on the timeline a live deal actually requires.
- FDA compliance history review
Review of a target's FDA interaction history, including Form 483 observations, Warning Letters, and deficiency responses, to surface compliance risk that standard commercial diligence typically misses.
- Predicate and pathway risk assessment
An honest read on whether the target's stated regulatory pathway and predicate strategy will actually hold up under FDA review, before that assumption is priced into the deal.
- Empanelment for ongoing portfolio-wide diligence
For funds with recurring healthcare deal flow, we act as a standing, pre-approved diligence resource across the pipeline rather than a one-off engagement rebuilt from scratch each time.
- Whether the technology works as claimed: the mechanism, the performance claims, and the evidence behind them.
- Test data quality and integrity: how the data was generated, and whether the methods would stand up to FDA review.
- Materials, biocompatibility, and chemistry for anything that contacts the body.
- Whether the planned bench, analytical, and clinical evidence matches the claims being made.
- FDA pathway and classification: 510(k), De Novo, PMA, or another route, and whether the claimed one is realistic.
- Predicate strength and intended-use claims.
- Prior FDA feedback, including pre-submission meetings and any deficiency correspondence.
- Submission readiness, likely timeline, and the cost of reaching clearance or approval.
- Manufacturing and quality system readiness: whether the product can be built consistently.
- FDA inspection and compliance history: Form 483 observations, Warning Letters, and how they were closed out.
- Data integrity across development, testing, and manufacturing records.
- For drug and biologic targets: the CMC package, and readiness for a pre-approval or GMP inspection.
Which regulator do you cover?
U.S. FDA. Our team's review and inspection experience is with FDA.
Can you review drug and biologic targets as well as devices?
Yes, for CMC and inspection readiness, led by Dr. Mamta Gautam-Basak, who spent 24+ years at FDA including senior CMC roles at CDER. Device diligence draws on Dr. Tanmay Jain's experience as a CDRH scientist and lead reviewer. Meet the team.
What do you need from the target?
Access to regulatory and quality documents, such as submissions, FDA correspondence, test reports, and design and quality records, plus time with the technical team.
Can we engage you for a single deal?
Yes. Single-transaction engagements and standing arrangements across a pipeline are both available.