We can help the healthcare companies in your portfolio reach FDA clearance or approval.

For many healthcare portfolio companies, the FDA is the largest gating risk, and few founding teams have reviewer-side experience in-house. We work directly with these companies to plan, prepare, and defend their submissions. You do not need to have used us for diligence, and we do not need to be an investor.

01 · What We Handle
How we support portfolio companies.
Pathway and submission strategy
510(k), De Novo, PMA, and pre-submission planning, matched to the product and its intended use before money is spent on the wrong route.
Submission preparation
Testing strategy, biocompatibility and chemical characterization, and the submission itself, prepared by a team that has reviewed these files from the FDA side.
Review response and deficiencies
When FDA sends a deficiency letter or an additional-information request, a structured response built on how reviewers actually evaluate answers.
Inspections and compliance
Form 483 and Warning Letter response and quality system readiness for devices, and CMC strategy and pre-approval inspection readiness for drug and biologic programs.
Engagements can be set up company by company, or as a standing arrangement across a fund's portfolio.
See all regulatory services → Pharma CMC and inspection readiness →
02 · The FDA Journey
Where we come in, from pathway to post-market.
A portfolio company can join at any stage. This is how our support maps to the FDA journey.
03 · Signals to Act On
Signs a portfolio company needs regulatory help.
A slipping submission date
The plan keeps moving because pathway, testing, or documentation questions stay open.
An FDA letter
A deficiency letter, an additional-information request, or a Form 483, with no clear response plan.
A change after testing
A design, material, or software change made after verification that may affect the submission.
A first U.S. filing from an India-based team
Founders planning U.S. entry who have not been through FDA review before.
An inspection on the horizon
A manufacturer preparing for a pre-approval or routine inspection.
No regulatory owner
Nobody on the team who has been through FDA review from the inside.
04 · Who You Would Work With
The team that does the work.
Tanmay Jain, PhD, Founder and Chief Scientist
Tanmay Jain, PhD
Devices, IVDs, and software

Founder and Chief Scientist. Former U.S. FDA CDRH scientist and lead reviewer with 300+ device submissions reviewed and co-author of ASTM F3718.

Dr. Mamta Gautam-Basak, PhD, Scientific Advisor
Dr. Mamta Gautam-Basak, PhD
Drugs, biologics, and inspections

Scientific Advisor. 24+ years at U.S. FDA, including senior CMC leadership at CDER, and global CMC regulatory strategy for INDs, NDAs, BLAs, and MAAs.

Supported by our scientific advisors, including a retired FDA research chemist and a professor of bioengineering. Meet the full team →

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Have a healthcare portfolio company that needs FDA help? Let's connect.

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