Life SciencesRegulatory Compliance
Submission assembly and the audit trail behind every document in it.
Today
With Emerant
What is changing in Life Sciences
The pressures we hear from leadership teams in this sector, and the ones the work below answers.
Validation needs proof
GxP and quality rules require evidence of how each process actually ran.
Long, costly cycles
A delay in trials or submissions is counted in months and millions.
Many reporting audiences
Investors, ESG frameworks and regulators each want a different view of the same data.
Data locked in documents
Lab, finance and regulatory records live in PDFs and spreadsheets.
How we help in Regulatory Compliance
The capabilities behind our work here. Open one to see what you get, how to start and the result it moved.
A short, evidence-led engagement that ends with a ranked shortlist, a cost model and an honest list of the things you should not automate yet.
- Start with
- AI Readiness Assessment3 weeks
Case studies in Regulatory Compliance
Regulatory Compliance~80%Projectedless auditor time per control planOn-Premise AI Internal Audit AssistantPublic agency administering EU funding · internal audit · close to €1 billion a year in paymentsRead the case
Regulatory Compliance13steps in every KYC case workflowKYC and AML Case Management Platform for a UK Compliance PracticeRisk and compliance practice · United Kingdom · KYC and AML reviews for financial-services and other UK organisationsRead the case
Regulatory Compliance€150MIFC facility the platform protectsESG Compliance Intelligence PlatformInvestment group · Europe · €150M sustainability-linked IFC facility with ESG covenantsRead the case
Microsoft Entra ID
Microsoft Power Automate
Microsoft Copilot
Microsoft Azure
Microsoft 365
Microsoft SharePoint
Microsoft Dynamics 365
Microsoft Power AppsWays to start in Regulatory Compliance
Fixed-scope first steps we have run against exactly this kind of problem.
Start here
AI Readiness Assessment
Three weeks to separate the processes where AI changes the economics from the ones where it is an expensive way to run a rule.
- Duration
- 3 weeks
- What you keep
- You leave with a defensible position for the board, built or not.
Lab
Emerging Tech Sprint
Two weeks testing one emerging technology against one of your real processes, ending in a recommendation you can act on or drop.
- Duration
- 2 weeks
- What you keep
- 'Walk away' is a legitimate outcome and we will say it.
Bars drawn to scale: one block is one week.
Our view
Submission assembly and the audit trail behind every document in it.
Bring us one process in Regulatory Compliance. We will tell you what it would take.
Not a proposal: a straight read on whether it is worth changing, what it costs and where it usually goes wrong in this sector.