The Challenge
Where scale-ups get stretched
Scaling a digital health product introduces compliance complexity that early-stage documentation was never built to handle. New features change your clinical risk profile. New markets introduce new regulatory obligations. New procurement targets require evidence standards your existing documentation does not meet.
Most scale-up compliance teams are stretched thin — maintaining what exists while trying to build what is needed next.
Our Deliverables
What we help scale-ups with
Documentation Management
Keeping your compliance documentation current as your product grows.
- Safety case updates for new releases
- Hazard log maintenance and review
- DTAC renewal and re-certification
Expansion Readiness
Building the evidence stack for new markets and procurement targets.
- New market regulatory mapping
- NHS framework application support
- International compliance advisory
Governance Infrastructure
Building compliance infrastructure that scales with the business.
- CSO retainer cover
- Board-ready governance reporting
- Investor due diligence support
See what's possible
Post-Release Safety Case Update
- Safety case current. Compliance maintained.
NHS Framework Application
- Framework listed. Recurring procurement pipeline opened.
Investor Due Diligence Support
- Due diligence passed. Deal confidence maintained.
Typical outcomes
The impact of compliance infrastructure that scales
reduction in
compliance
management overhead when CSO retainer replaces in-house build
faster
response
to investor due diligence requests when regulatory documentation is maintained continuously
“Scale-ups that treat compliance as infrastructure rather than a project are the ones that convert the procurement opportunities their competitors miss.”
Dr Jide Idowu, Founder, SDHA
- Safety Case Update
Post-release clinical safety case update for a telemonitoring platform following a significant feature release. Hazard log updated, new risks assessed, and CSO sign-off secured within four weeks.
- Framework Application
NHS framework application support for a mental health digital tool. Full evidence pack compiled and submission managed end to end. Product listed on framework within the application window.
- Due Diligence
Regulatory due diligence package produced for a Series A raise. Investor-ready regulatory position statement, gap-closure roadmap, and MHRA pathway documentation delivered in three weeks.
