Regulatory consultants
Take on more clients. Keep every dossier in one workspace.
One secure workspace shared with your clients and their notified body, where AI checks completeness and content against the requirements — so each engagement takes less effort and your team can serve more and also smaller clients.
Scattered files, heavy reading and no view of the review.
Many clients, many inboxes.
Dossiers for every client move through email and shared drives, and nobody has the full picture.
The reading is the heaviest burden.
Checking completeness and validating content against regulatory requirements eats the hours your experts should spend advising.
You can’t see where the review stands.
Little visibility into the notified body’s progress makes it hard to plan, and hard to tell the client when they will reach the market.
How ComplAi lets you serve more clients with the same team.
One data room for all three parties.
Consultant, manufacturer and notified body work in the same place, with every document, question and non-conformity on record.
AI completeness and content checks.
Run the pre-flight check on a client’s technical file before it is submitted: gaps, missing evidence links and likely non-conformities, ranked, each cited to the source passage.
More capacity, not more hours billed for reading.
Each engagement takes less effort, so you can take on the next client without the next hire — and reach smaller clients with smaller budgets.
Audits as a service, across your whole portfolio
Many consultancies also assess against commercial standards — for example a standard a retailer requires of every supplier. In ComplAi you distribute the requirements, each client completes its self-assessment with evidence in its own data room, and you carry out the independent assessment and follow the results across all your clients in one place.
Accelerate
AI reads and checks; your consultants decide.
Collaborate
Client and consultant in one data room.
Prove
Every finding cited to its source; a trail your clients can defend.
Sustain
Run management systems continuously, not audit to audit.
Beyond the dossier: run your clients’ management systems
The same workspace runs MDR certification, cyber security and every management system your clients hold: ISO 13485, 9001, 14001, 45001, 50001, 42001, GDPR and CSRD/ESRS. ISO standards share the Harmonized Structure, so about 70% of the work is common — one context, risk register, policy, audit programme, CAPA log and management review, with a thin layer per standard.
ComplAi carries the manual and semi-automated ~60% of controls that run a management system day to day. Integrated ticketing surfaces overdue items before they become findings, and an MCP connector links ComplAi to your clients’ own AI assistants and agents. A small team can run many clients’ systems continuously, not just prepare them for audit.
Supplier questionnaires for your clients run in the same place — see Supplier assessment.
Compliance cockpit · all clients
- 4Overdue
- 9Due in 30 days
- 38Upcoming
- 112Complete
Needs attention
| Item | Standard | Deadline | Due |
|---|---|---|---|
| Re-evaluate sterilisation supplier · Client A | ISO 13485 · §7.4 | Wed 7 Oct | 9 days overdue |
| Review privileged access · Client C | ISO 27001 · A.5.18 | Sun 11 Oct | 5 days overdue |
| Management review · Client B | ISO 9001 · §9.3 | Tue 13 Oct | 3 days overdue |
| Internal audit: design controls · Client A | ISO 13485 · §8.2.4 | Thu 15 Oct | 1 day overdue |
Start with one team, expand on your terms.
Pilot one use case with one team
Upload documents, configure one questionnaire or standard and invite users. No IT integration is required to begin.
Measure against your baseline
Compare time per task or per audit with your current baseline within the first pilot cycle.
Roll out, then connect
Extend to further teams, clients or suppliers. Every use case shares one document library.
Weeks 1–4
Pilot one use case with one team
Months 2–6
Roll out across teams, clients or suppliers
Month 6+
Connect use cases in one document library
- 60% time saved on document exchange and collaboration (DNV assessors)
A consultancy helping vendors to financial institutions become DORA compliant is piloting ComplAi and vouches for the capacity and efficiency gains.
Frequently asked questions
Will this reduce what I can bill?
It changes what you bill for. Less time on reading means capacity for more clients and room for productised, retainer-style assessment — with a cited audit trail that justifies the fee.
Why not upload documents to a generic AI assistant?
A general assistant is fast but inconsistent and hard to trace. ComplAi checks against machine-readable requirements, gives the same result every time, and cites every finding to the exact passage.
Do my clients’ notified bodies need to use ComplAi?
No. You can work with your clients alone, and connect to the same data rooms when the notified body is on ComplAi.
Where is client data hosted?
All data is hosted in the EU. ComplAi is ISO 27001 certified and GDPR compliant.
See it on one of your own engagements.
Run the pre-flight check on a client file, or book a demo with your team.