Clinical expertise.

Digital health advisory.

Clinical expertise. Digital health advisory.

For digital health founders, NHS commissioners, and health tech investors
navigating regulation, compliance, and market entry.

Typical response: 1 business day

Teams choose us for reliable delivery

Advisory Outcomes

See what's possible

Real advisory outcomes for digital health teams navigating regulation, procurement, and product development.

REGULATORY
DTAC
DTAC Self-Assessment
INPUTS
Existing product documentation
ACTION
Review
Gap Analysis
Evidence Map
RESULT
CLINICAL SAFETY
DCB0129
Clinical Risk Documentation
INPUTS
Product Scope & Clinical Context
ACTION
Hazard Log
Safety Case
Sign-off
RESULT
FINANCE
PROCUREMENT
NHS Bid Readiness
INPUTS
Tender Specification & Product Evidence
ACTION
Align
Map Compliance
Draft Submission
RESULT
REGULATORY
MHRA
SaMD Classification Review
INPUTS
Product Description & Intended Use
ACTION
Classify
Route
Evidence Strategy
RESULT
MARKET ENTRY
NHS
UK Market Access
INPUTS
International Product Profile
ACTION
Assess
Localise
Compliance Map
RESULT
INTERNAL
GOVERNANCE
Clinical Safety Officer Support
INPUTS
Organisation's Safety Requirements
ACTION
Review
Framework
Ongoing Advisory
RESULT

How we work

A process built for results

Clear methodology, consultant-led accountability, and zero mystery reasoning. We know how we get from intake to impact.

Step 01
Discovery & Scoping

We map your regulatory position, product stage, and procurement goals

Step 02
Framework & Evidence Design

We build the documentation, safety cases, and compliance evidence your pathway requires

Step 03
Review & Assurance

Clinical review, independent sign-off, and gap resolution before submission

Step 04
Launch + Ongoing Advisory

Live support for commissioner meetings, investor due diligence, and iterative updates

Prefer to talk first?

Industries

Built for digital health

We tailor to your data + compliance needs

* We tailor every solution to your specific product requirements and compliance needs.

Solutions

ALLO PRODUCTS

Built on a real clinical problem

01
Allo Workplace
Occupational Health
HR Technology
40%

faster assessment-

to-support pathway

Structured screening for ADHD, autism, and dyslexia in professional settings.

Problem
Employers lack a clinically validated, scalable tool for identifying neurodivergent employees early; leaving support needs unmet, productivity affected, and legal duties under the Equality Act unaddressed.
Approach:
Allo Workplace delivers AI-assisted pre-assessment screening, workplace needs analysis, and a structured referral pathway, designed for HR teams and occupational health providers.
Outcome:
Faster identification, reduced time to reasonable adjustments, and a defensible clinical evidence trail for employers.
02
Allo Clinical
CLINICAL SaMD
Right to Choose

capacity for

pre-assessment

triage

AI-powered intake for adult ADHD and autism diagnostic pathways.

Problem
Adult neurodevelopmental waiting lists run 2–5 years across the NHS. Clinicians spend disproportionate time on intake, history-taking, and documentation before a single diagnostic decision is made.
Approach:
Allo Clinical is a regulated Software as a Medical Device (SaMD) that automates structured history collection, symptom mapping, and clinical documentation — integrated into existing Right to Choose provider workflows.
Outcome:
Reduced clinician administrative burden, shorter patient wait times, and standardised pre-assessment data quality across providers.
03
Allo Paediatrics
CAMHS
Paediatric Pathway
5–17

Earlier

identification

at school-age

Structured developmental screening for children aged 5–17.

Problem
CAMHS referral thresholds are high and waiting times are long. Parents and teachers observe concerning behaviours months or years before a child reaches formal assessment — with no structured tool to document and escalate that evidence.
Approach:
Allo Paediatrics provides a structured developmental questionnaire system for parents, teachers, and GPs — generating a clinical-grade evidence report that supports CAMHS referral and accelerates triage decisions.
Outcome:
Earlier, better-evidenced referrals, reduced CAMHS gatekeeping friction, and improved outcomes through timely identification.

What clients say

Our stack

GET STARTED

Let's talk about your compliance

Book a discovery call or send us a message. We’ll get back to you.

30 minutes to map your regulatory position. No pitch, no pressure; just a focused conversation about your digital health challenge.

Schedule a discovery call

Tell us about your product, regulatory position, or advisory need.

We'll only use your info to respond to your inquiry.

FAQ

Common questions

Everything you need to know before we start working together.

It depends on the scope. A DTAC self-assessment support engagement typically runs 4–6 weeks. A full DCB0129 clinical safety documentation package is usually 6–10 weeks. Ongoing CSO support is structured as a monthly retainer with no fixed end date. We scope every engagement at the discovery call so you know exactly what to expect before we start.

Yes — and it’s where early investment in compliance pays off most. Many founders wait until a procurement opportunity arises before addressing regulatory requirements, which costs time and deals. We help early-stage teams build the right foundations from the start so compliance becomes a commercial asset, not a last-minute hurdle.

Yes. We support teams through NHS and ICB procurement processes including tender preparation, compliance evidence mapping, and DTAC submission. We understand what commissioners look for and how to structure evidence to meet those expectations.

DCB0129 is the NHS clinical risk management standard for health IT systems. If your product is used in a clinical setting, interfaces with patient data, or is being procured by an NHS organisation, you almost certainly need it. It requires a documented clinical safety case, a hazard log, and sign-off by a qualified Clinical Safety Officer. We handle all of this.

Yes. We advise international digital health companies seeking to enter the UK market — covering regulatory positioning, DTAC readiness, NHS procurement strategy, and clinical safety requirements. We also support GCC-based health technology investors and health system buyers navigating the UK digital health landscape.

Within one business day of your call, we send a written summary of your regulatory position and a proposed engagement scope. If you are ready to proceed, we issue a fixed-scope agreement and begin onboarding. There is no obligation after the discovery call; it is purely a diagnostic conversation..

Yes. We regularly step into engagements mid-stream; reviewing existing hazard logs, safety cases, DTAC evidence packs, and regulatory submissions. We identify gaps, correct errors, and get your documentation to a standard that holds up under scrutiny. You do not need to start from scratch to work with us.

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