Regulatory Expertise for the
Biotechnology Industry
Breakthrough science. A handful of people. And a runway that ends in quarters, not years.
Breakthrough science. A handful of people. And a runway that ends in quarters, not years.
Emerging biotech runs on a particular imbalance: a molecule that could change medicine, and an organization too lean to carry it through the regulatory system that decides whether it ever reaches a patient. The founding team knows the biology cold and, by design, is thin everywhere else — no head of regulatory, no quality system, no one who has walked an IND through the FDA or a BLA to approval before. Hiring that team full-time, years before you need all of it, burns the runway you raised to generate data. We solve the imbalance the way the best-run biotechs do: senior regulatory and quality leaders embedded fractionally, scaling their involvement to your stage — so you buy judgment when you need it, not headcount you don't.
Every avoidable delay is measured twice — in months lost and in the dilution of the raise that covers them.
Every avoidable regulatory delay is paid for twice: in months lost, and in the dilution to cover them.
Of drug candidates that enter clinical trials never reach approval. The regulatory strategy set before the first patient often decides which side of that line you land on.
The capitalized cost of bringing one new therapeutic to market. Most of that is spent proving to a regulator that the science holds — which makes regulatory strategy a financial discipline, not a formality.
A single mishandled FDA interaction — a clinical hold, a Refuse to File, a Type B meeting you weren't ready for — can cost a full financing cycle. The first one usually lands before you've hired anyone to run it.
A biotech is defined by the stage it's in — and each stage needs a different depth of regulatory and quality leadership. We meter ours to match, so you're never over-built or caught short at the moment it counts.
From first IND-enabling study to the day you file, one team that scales up and down with you.
Target Product Profile, regulatory strategy, and the IND-enabling plan — so the nonclinical package you build is the one the agency will actually want to see.
IND and CTA authoring, the pre-IND meeting, and the CMC section that keeps you off clinical hold. The submission that lets dosing begin on schedule.
A quality system sized to your stage, GCP oversight, and the End-of-Phase-2 meeting that sets the terms of your pivotal trial.
Process validation, GMP readiness, expedited-pathway strategy, and the pre-BLA groundwork — the quality infrastructure a commercial product demands.
Submission assembly and publishing, pre-approval inspection readiness, and the launch-quality systems that carry you from approval into the market.
The people who lead your regulatory and quality work have done it before — through approvals, through inspections, through the meetings that don't go to plan. What changes for a biotech is how you engage them: not as a department you fund full-time before you can, but as leadership you scale up and down as the program moves.
A senior regulatory or quality head embedded in your team — accountable for the strategy, present for the decisions, priced to your stage.
A defined deliverable with a defined end — a submission, a meeting package, a quality system stood up before an inspection.
None of these come from bad science. They come from a regulatory and quality function that lagged the biology by a stage — and got caught.
Every one of these traces back to a regulatory function that lagged the biology by a stage.
Clinical races ahead while manufacturing lags. Then the CMC section holds the whole IND on the launch pad — or worse, triggers a clinical hold the science never earned.
A pre-IND or Type B meeting is a scarce, decisive asset — and a team facing its first one rarely knows how scarce. Walk in underprepared and you spend a financing cycle recovering.
A quality system bolted on the quarter before a pre-approval inspection is a system with no history — and history is exactly what an investigator reads. Phase-appropriate means starting sooner than feels necessary.
Doing the next obvious experiment instead of the one the label will need. Without a regulatory strategy pointed at the target profile, a program can generate years of data the agency never asked for.
A partner or acquirer's regulatory review finds the gap you'd normalized — a thin master file, an unsigned validation, a reportability call never documented. Value walks out the door with it.
The entire regulatory memory living in one contractor's head. When they roll off, the strategy, the agency rapport, and the rationale for a hundred decisions leave with them.
Life sciences is all we do, and emerging biotech is where we do our best work. Your leads are senior regulatory and quality practitioners who have run INDs, sat across the table from the FDA, and carried programs to approval — for venture-backed biotechs, not just large pharma with infinite resources.
We know the difference between phase-appropriate and gold-plated, and we spend your capital like it's finite — because we know it is.
Small molecules, biologics, and the novel modalities — antibodies, peptides, oligonucleotides — each with its own regulatory and CMC terrain. Your lead has crossed yours.
We can present the regulatory story to your board and hold up under a partner's technical diligence — because we've built the programs that diligence examines.
The practitioner who sets your strategy is the one who executes it. No pitch-team-to-junior-staff handoff after the agreement is signed.
The biotech journey draws on the full range of what we do. These are the services emerging programs reach for most.
The section most likely to hold up a biotech IND — authored and defended so manufacturing keeps pace with the clinic.
Explore CMC →Pre-IND, Type B, and End-of-Phase meetings prepared so your scarce agency interactions land the way they need to.
Explore Meetings →Breakthrough, Fast Track, and other expedited routes — mapped to your program before the window to claim them closes.
Explore Pathways →Tell us where your program stands — approaching a first IND, prepping a pivotal, staring down a pre-approval inspection, or raising the round that funds all three. We'll scope the regulatory and quality leadership to match, and respond within one business day. All inquiries are strictly confidential.
