A specific perspective the in-house team does not hold
Multi-month engagements for organisations with clinical-affairs, regulatory-affairs, and market-access already in place.
You are not buying capacity; you are buying a perspective. We name the substrate, we name the refusal, we route the rest through NDA.
Read what is typical, then read who we say yes to, then read what we will not do.
What this page is
An audience surface for corporate-scale engagements
An audience surface for organisations whose engagements run at corporate scale (multi-month, multi-clinician, named-experts-in-the-room), who care more about defensibility than throughput.
Typical scope
Three shapes the engagement takes
Manufacturer-evidence dossier
The clinical-affairs document the in-house team would write if it had three more people and twelve more months. Anchored on the GNL evidence base; reviewed by named clinicians; ready for regulator, payer, or peer-review submission. Review is independent; reviewed-by is never endorsed-by.
Device-class market-entry strategy
Regulatory positioning (CE and UKCA; not FDA), clinician-led evidence framing, payer narrative, named-clinician round-table. Worked examples: continuous-lactate device class, CGM accuracy positioning. Engagement-side detail under NDA.
Bespoke agent infrastructure
Per-client agent stacks behind your own keys, your own data, your own ethics gate. Built to enterprise standard; the same architectural pattern that powers GNL Grace. Multi-month engagements.
Who passes the filter
Who we say yes to
We say it in plain English so a clinical-affairs team can self-select before any call.
If you are working on lactate, particularly lactate paired with CGM for insulin dosing, exercise, or critical-care monitoring, we are interested. We become your evidence and ethics partner.
If you are building a bolus advisor and need IOB modelled honestly, we are interested. We will not let you ship a number you cannot defend.
If you are an AID manufacturer adding exercise or IOB features and you want a partner that operates in lockstep with the evidence rather than around it, we are interested.
Who we say no to
The refusal sits at the same weight as the accept routes, on purpose. The substrate decides who we work with, not the size of the cheque.
If you are a CGM manufacturer looking to enter the non-diabetes wellness market, we are not the team for you. Our internal will not let us support a signal we do not believe is good enough for the people you would be selling it to.
Tier
Strong Signal or Bullet Proof
The refusals
What we will not do
Procurement-led “fit-everything” pitches.
Marketing register on clinical claims.
Endorsement-style reviews. We review; we do not endorse. The review is paid for by the engagement, not by the manufacturer of the tool being reviewed.
FDA pathway work as a lead deliverable. We carve out CE and UKCA; we refer FDA to a partner consultancy.
What the work looks like
See a sample dossier
When we take on a bigger piece of work, one of the things we hand over is a dossier: a single, careful document that shows exactly how a product or service holds up. It is what you would put in front of a regulator, a senior clinician, or an insurer when they ask the hard questions. The two samples below are taken from the dossiers behind the GNL launch.
We have left the opening half of each one readable: who the company is, how it is set up, the rules it works under, how it is positioned, and the standards it writes to. The detailed inner workings are blanked out, and clearly marked where they have been removed. In a real piece of work that detail is shared with the client privately, under a confidentiality agreement. What the sample shows you is the shape, the depth, and the standard of the finished thing.
GNL Site Dossier, structural sample
This one covers the wider platform: who the company is and how it is set up, its insurance and risk position, the rules it works under, the story behind it, and the standards it writes to.
Grace Dossier, structural sample
This one covers Grace, the diabetes education advisor: what Grace is, how it works alongside the other tools, where it sits with the regulator, and the safety limits built around it.
The first conversation
Single inbox, no procurement portal, no first-call NDA
Single inbox, no procurement portal, no first-call NDA. The first conversation is rarely about what we sell; it is about whether the engagement fits the substrate. No tier sheet, no commitment, no expectation of payment for an introductory call. If we cannot help, we say so and recommend who can.