Pharma · Medtech · Healthtech

Better decisions. Finished work. Wherever you work.

Expert AI services for pharma, medtech and healthtech. Run them in the VITAL platform with your team, or inside Claude with VITAL plugins, connectors and skills.

Work you can stand behind

VITAL platformSigned
Regulatory Pathway Decision · Decision memo

510(k), De Novo, or wait for more evidence?

Each route scored on cost, time, evidence and risk, with what would change the answer.

Every claim checkedGaps marked
Reviewer signed · M. HaleKept in the record
In ClaudeVITAL connector
Which route for our AI software device: 510(k), De Novo, or wait?
VITAL · Regulatory Pathway Decision

The same decision memo, in the same format. Verify checked every claim against its source.

Open in VITAL for sign-off →
One deliverable, two places. Start in Claude, move to the platform when the work needs sign-off.
Service-as-Software

Software gives you a tool. VITAL gives you the result.

Software gives you a tool to do the work. Service-as-Software does the work and gives you the result: a finished deliverable from expert agents, at software speed. You make the call.

Consulting or agency

Weeks, at day rates.

What you buy
People’s time
Who does the work
Consultants
Time to result
Weeks
What you can check
A slide deck
General AI assistant

You do the work, with no set method.

What you buy
Access to a tool
Who does the work
You
Time to result
Depends on you
What you can check
A chat transcript
VITAL

The work done to a set method, every claim checked.

What you buy
A finished deliverable
Who does the work
Expert agents. You decide
Time to result
Minutes to hours
What you can check
Every source, every gap, who signed
Two ways to work

Work in VITAL,
or bring VITAL into Claude.

The platform is for teams that want to work with expert agents under control. Claude is for professionals who want expert work inside the tool they already use.

VITAL Platform

Work with expert agents, under control.

For teams that want to work in a hybrid, controlled way with expert agents.

  • Governed work: human checkpoints, named sign-off and a kept record
  • The pharma ontology
  • A shared workspace for people and agents
  • Packs, and your own workflows

Day to dayHumans and agents in one document. Reviews and decisions in the flow. Nothing goes out unsigned.

VITAL for Claude

Expert work, without changing tools.

For professionals who already work in Claude and want industry-grade results there.

  • Host plugins on Capabilities (TRUSTED, Verify, Digital Health, Navigator)
  • MCP connectors on Tools & MCP — same products that run inside Brief, Panel and Analysis
  • A set method for each task, with every claim checked against its source
  • The same output format every time, reusable by colleagues

Day to dayAdd VITAL to Claude and keep working where you are. The price is shown before each job.

Add it in two steps
  1. 01Browse Tools & MCP and mint a Connect key.
  2. 02Install the Capabilities plugin for your function in Claude.

Connectors guide →

Same services, same standards, same sources.
Start in Claude, move to the platform when the work needs sign-off.

Services

What do you need done, or decided, today?

Pick your function. Each service answers one question you already own and returns one finished deliverable.

Regulatory Affairs

Know your pathway, and what must be true, before you file or meet the agency.

All Regulatory services
  • Analysis · coming soon

    Regulatory Pathway Scan

    Which filing pathway is plausible, and what must be true before you file?

    Platform
  • Brief · decision memo

    Regulatory Pathway Decision

    510(k), De Novo or wait for more evidence: which route, scored on cost, time, evidence and risk?

    Platform
  • Brief · comparison

    Device Pathway Comparison

    How do 510(k), De Novo and PMA compare for a new AI software device?

    Platform
  • Brief · assessment

    Regulatory Precedent Assessment

    Will the authority reason the same way on your file as on a comparable product?

    Platform
  • Brief · scan

    AI Device Guidance Scan

    What US and EU guidance on AI-enabled device software came out this year?

    Platform
  • Brief · diagnosis

    Review Delay Diagnosis

    Why is the agency asking repeated questions on your submission?

    Platform
  • Panel · rehearsal

    Regulator Meeting Rehearsal

    How will the pre-submission meeting go, with simulated regulator, statistician and clinician?

    Platform
  • Panel · red team

    Submission Strategy Red Team

    Where does your FDA submission strategy break?

    Platform

Market Access, Pricing and HEOR

Get to the first reimbursed patient with fewer surprises.

All Market Access services
  • Analysis · coming soon

    HTA Assessment

    What did the HTA body rely on, and what does that precedent allow?

    Platform
  • Brief · decision memo

    Market Entry Sequencing

    Which market first, and in what order?

    Platform
  • Brief · decision memo

    Pricing and Contracting Position

    List price, lower price or outcomes-based agreement?

    Platform
  • Brief · decision memo

    Evidence Generation Strategy

    Randomized trial, external control or real-world evidence?

    Platform
  • Brief · comparison

    HTA Body Comparison

    How do NICE, G-BA and HAS differ on comparators, evidence and price?

    Platform
  • Brief · plan

    EU Market Access Plan

    What is the path from HTA submission to first reimbursed patient?

    Platform
  • Panel · red team

    Payer Dossier Red Team

    Will the value dossier survive payer review?

    Platform
  • Panel · go/no-go

    Geographic Entry Board

    Enter this country now, later or not at all?

    Platform

Medical Affairs

Turn the evidence into a position your medical team can defend.

All Medical Affairs services
  • Analysis · coming soon

    Patient Journey Engine

    Where do patients get lost on the way to treatment?

    Platform
  • Brief · overview

    Disease Area Overview

    How big is the burden, how are patients treated, where does care fall short?

    Platform
  • Brief · assessment

    Surrogate Endpoint Assessment

    Is this surrogate endpoint good enough evidence of benefit?

    Platform
  • Brief · landscape

    Real-World Data Vendor Landscape

    Which RWD vendors fit our evidence plan?

    Platform
  • Panel · document review

    Manuscript and Abstract Review

    Does the manuscript claim no more than the data allow?

    Platform
  • Panel · go/no-go

    Indication Expansion Board

    Should we invest in a new indication, and what evidence must exist first?

    Platform
  • Mission · in build

    Ad Board Mission

    Frame the decision, convene the right experts, synthesize the recommendation.

    Platform

Brand and Marketing

Launch with a position, and claims, that hold up in review.

All Marketing services
  • Brief · decision memo

    Brand Positioning Decision

    Which positioning should the brand lead with at launch?

    Platform
  • Brief · assessment

    Comparative Claim Assessment

    Does the head-to-head evidence support a superiority claim?

    Platform
  • Brief · overview

    Promotional Claims Rules Overview

    What rules govern promotional claims in this market?

    Platform
  • Brief · diagnosis

    Launch Uptake Shortfall Diagnosis

    Why is the launch behind forecast?

    Platform
  • Panel · document review

    Launch Claim Set Review

    Which claims in the detail aid would a review committee challenge?

    Platform
  • Panel · red team

    Launch Plan Red Team

    Where does the launch plan break, from payer, competitor and brand angles?

    Platform
  • Panel · go/no-go

    Launch Readiness Board

    Are we ready to launch in the planned window?

    Platform
  • Panel · estimate

    Peak Market Share Range

    What share will the product hold at peak?

    Platform

Clinical Operations

Keep trials on time, and know early when they will not be.

All Clinical Operations services
  • Brief · comparison

    Trial Design Comparison

    Site-based, hybrid or decentralized Phase 3?

    Platform
  • Brief · scan

    Competing Trials Scan

    Which recruiting trials compete for your patients?

    Platform
  • Brief · diagnosis

    Enrollment Stall Diagnosis

    Why is enrollment behind target?

    Platform
  • Brief · plan

    Trial Enrollment Recovery Plan

    How do we recover, with owners and the first move?

    Platform
  • Panel · document review

    Protocol Synopsis Review

    Is the protocol synopsis feasible and safe to take to site selection?

    Platform
  • Panel · go/no-go

    Phase 2 to Phase 3 Transition Board

    Does the Phase 2 package meet the bar for Phase 3?

    Platform

Pharmacovigilance and Safety

Tell a real signal from noise, and respond in proportion.

All Safety services
  • Brief · diagnosis

    Safety Report Rise Diagnosis

    Is a rise in adverse event reports a true signal?

    Platform
  • Brief · assessment

    Benefit-Risk Position Assessment

    Does the benefit-risk balance hold after new safety data?

    Platform
  • Brief · scan

    Class Safety Communication Scan

    What did FDA and EMA say about this drug class in two years?

    Platform
  • Panel · divergence

    Safety Signal Divergence

    Where do specialists disagree on a label change?

    Platform
  • Panel · benefit-risk

    Emerging Safety Signal Reassessment

    Is the balance still favorable, and what response fits?

    Platform
  • Panel · prioritization

    Safety Signal Investigation Order

    Which open signals do we investigate first?

    Platform

Quality and Manufacturing

Find the root cause, and release changes with confidence.

All Quality services
  • Brief · diagnosis

    Batch Failure Diagnosis

    Why does a quality attribute keep failing across batches?

    Platform
  • Panel · round table

    Site Transfer Round Table

    Quality, regulatory, clinical and BD views on moving a product to a new site.

    Platform
  • Panel · go/no-go

    Manufacturing Site Transfer Board

    Is the receiving site ready to take over supply?

    Platform
  • Panel · benefit-risk

    Post-Marketing Requirement Review

    Do the first post-marketing results change the balance?

    Platform

Corporate Development and BD

Make portfolio and deal calls on evidence, not on the loudest voice.

All Corporate Development services
  • Analysis · coming soon

    Competitive Landscape

    Who else is in this market, and on what evidence?

    Platform
  • Brief · decision memo

    Asset Go/No-Go

    Advance, pause or license out the asset?

    Platform
  • Brief · decision memo

    Build, Partner or Buy

    Build, partner or acquire the capability?

    Platform
  • Brief · overview

    Company Overview

    What does this company do, how is it financed, where does it stand?

    Platform
  • Brief · comparison

    Deal Structure Comparison

    License, co-development or acquisition?

    Platform
  • Panel · go/no-go

    In-Licensing Go/No-Go Board

    In-license this asset on these terms?

    Platform
  • Panel · estimate

    Probability of Success: Phase 3 Entry

    What are the odds this asset reaches approval?

    Platform
  • Mission · in build

    Ecosystem Navigator

    Map an entire market segment.

    Platform

Public Affairs and Policy

See policy coming, and walk into the room prepared.

All Public Affairs services
  • Analysis · coming soon

    Public Affairs Dossier

    What does the public record support for this policy position?

    Platform
  • Brief · scan

    EU Policy Horizon Scan

    Which pending EU measures affect your product class?

    Platform
  • Brief · landscape

    Policy Stakeholder Map

    Who holds which position on the issue, and who convenes whom?

    Platform
  • Brief · plan

    Legislative Engagement Plan

    How do we engage from now to the committee vote?

    Platform
  • Panel · rehearsal

    Stakeholder Rehearsal

    How will payer, clinician, advocate and ministry react?

    Platform
  • Panel · red team

    Consultation Response Red Team

    Will the consultation response hold up with the authority?

    Platform

Digital Health and Innovation

The functions a startup cannot hire yet, running today.

All Digital Health services
  • Brief · assessment

    Digital Therapeutic Evidence Assessment

    Is the evidence enough for payer coverage?

    Platform
  • Brief · outlook

    DTx Reimbursement Outlook

    Will the DTx reach national reimbursement in this market within two years?

    Platform
  • Brief · scan

    Prescription DTx Field Scan

    Which DTx are cleared in the US and EU, by purpose?

    Platform
  • Brief · overview

    Health-Tech Due-Diligence Readiness

    Are we ready for investors, and how much should we raise?

    Platform
  • Panel · round table

    DTx Launch Round Table

    How do we launch a prescription DTx in the US?

    Platform
  • Panel · prioritization

    Digital Feature Prioritisation

    Which features of the digital companion do we build first?

    Platform
  • Panel · Delphi

    Endpoint Selection

    Which primary endpoint should the pivotal study use?

    Platform

Brief: under 2 min · Panel: 10–20 min · Analysis: 15–40 min, coming soon · Mission: in build

See the full catalogue
For decision-makers · Decision Challenge

Test the decision before you take it.

The ontology maps a strategic decision’s assumptions, evidence and dependencies. A cross-functional panel then challenges it.

Talk to usPlatform only
You get
01
The weakest assumption
02
What would reverse the call
How a service runs

You ask. Experts work. Every claim is checked.

01

You ask

Pick a service and give it your context: the question, the product, the market.

02

Experts work

Expert agents work to the service’s set method, the same way every time.

03

Every claim is checked

Each claim is checked against its source before the result comes back. Gaps say gap.

04In the platform

Your reviewer signs

In the platform, a named person signs before the work moves on, and the record is kept.

Five ways to hire

From one question
to a signed engagement.

  1. 01 Orient Ask your Chief of Staff where to start, and which service fits. Free · instant
  2. 02 Brief One expert answers one question, written up with every source shown. Under 2 min
  3. 03 Panel Three to five experts deliberate. Where they split is kept, not averaged. 10–20 min
  4. 04 Analysis A job done to a set method, from a plan you approve first. 15–40 min · coming soon
  5. 05 Mission A governed engagement with named roles and gates you sign. In build
Why trust it

Work you can stand behind.

We evaluate; we never certify.

Set methods

Every service follows a method built for the industry, with the same headings every time.

Checked sources

Every claim is checked against its source before the result comes back.

Gaps marked

What could not be sourced is marked as a gap, never filled in.

Named sign-off

In the platform, a named person signs and the record is kept.

Oncology launch readiness · EU5 market entry

In the platform, the record is kept.

Before you sign something, you need three things in front of you.

Industries

Built for the way your industry decides.

Pharma and biotech

Commission the outcome. Keep the record.

Flagship services
  • HTA Assessment
  • Market Entry Sequencing
  • Launch Readiness Board
Best way to start

The platform, for a team and a commissioned deliverable. Claude, for individual leads who already use it.

Read more
Medtech and diagnostics

From intended use to reimbursement, without the agency wait.

Flagship services
  • Regulatory Pathway Scan
  • Device Pathway Comparison
  • Regulator Meeting Rehearsal
Best way to start

Claude first, for classification, pathway and predicates. Then the platform for the submission team.

Read more
Healthtech and digital health

The functions you can’t hire yet, running today.

Flagship services
  • Regulatory Pathway Decision
  • Digital Therapeutic Evidence Assessment
  • DTx Reimbursement Outlook
Best way to start

Claude first. The platform when the team grows.

Read more

Also for boutique consultancies, for the individual whose name goes on the work, and for the expert whose method should run when they are not in the room.

Start where you already work.

Plans for the platform. A price per job in Claude, shown before you run it.