How We Work

Engagement models

Four ways to engage us

Fractional leadership

A named senior operator sitting in your VP of Regulatory, Quality, CMC or Clinical seat — one to three days a week, rolling monthly. For companies that need the judgment before they can justify the headcount.

Defined-scope project

Fixed deliverable, fixed date. An IND, a CMC section, a QMS build, a validation package, a remediation plan. Scoped in writing before it is priced, rather than an hourly estimate that drifts.

Embedded team

Consultants working within your environment, your document control and your daily meetings for the length of a programme. The right answer when the constraint is capacity rather than knowledge.

Independent review

Audits, due diligence, practice inspections and second opinions — where having no stake in the outcome is the entire value. Findings are delivered to you in writing, unedited.

Every engagement names the individual doing the work before you sign. If that person has to change, you approve the replacement. Senior people in the pitch and junior people on the file is the standard failure mode of this industry, and we do not operate that way.

Predictable, itemised invoicing

How pricing and invoicing work

Four practices that exist because the alternative has cost somebody, usually before they came to us.

In practice

Time and materials work is invoiced monthly with the detail behind it — by person, by programme and by task — against an estimate that is re-baselined quarterly against what is actually happening.

When a workstream is trending more than about ten per cent over its estimate, you hear about it at the point we notice, not at the point the invoice arrives. Volume assumptions get revisited on the same schedule, in both directions.

Pass-through costs — subscriptions, laboratory fees, pre-approved expenses — are invoiced at cost with the supporting documentation attached. We do not mark them up, and we take nothing on what you buy from anyone else.

Your data and documents are yours. On request or at the end of an engagement, you receive the complete work product in native and structured formats, with transition assistance if you want it.

What that means for you

Scope before price. We write down what the deliverable is, then price it — not the other way round.
An early warning, not a late surprise. Anything trending over its estimate is flagged while you can still make a decision about it.
Nothing marked up. Pass-throughs at cost, with receipts. We earn on our time and nothing else.
Nothing locked in. Records are structured and portable from the first day, so leaving is a handover rather than a rebuild.

The arc of a programme

Where you are determines what a first conversation looks like

Five stages, in order. Find the one you are standing in.

01

Concept & feasibility

Pathway and classification analysis. Product profile definition. Competitive and IP landscape. Reimbursement screen. A go / no-go recommendation with a number attached to it.

02

Nonclinical & CMC

Phase-appropriate CMC plan. GLP toxicology strategy. CDMO selection and qualification. Analytical development. Formulation, stability and clinical supply.

03

IND / IDE & first-in-human

IND or IDE assembly and submission. Pre-IND meeting strategy. Protocol and Investigator's Brochure. Site and CRO selection. Safety function stood up before first dose.

04

Clinical development

Phase 2 and 3 delivery, risk-based oversight and data governance under E6(R3). Aggregate safety reporting. Agency meetings and information requests.

05

Submission, launch & lifecycle

NDA, BLA, PMA or 510(k) assembly and support through review. Advisory committee preparation. Process validation and tech transfer. Post-market safety follow-up, change control and periodic reporting.

Most clients reach us at stage 02 or 03, with a programme already moving. That is normal, and it is workable. It is also more expensive than stage 01, because by then the decisions that constrain the regulatory pathway have usually already been made in the lab.