AI DEVELOPMENT

Agentic AI for drug safety, built to pass validation.

Most PV teams don't need another AI platform. They need someone who knows both the safety database and the model — and can put the two together with evidence an inspector will accept. That's what we build.

WHY NOW
~⅔
of a typical PV budget is consumed by case processing alone
73%
of pharma organizations are planning or deploying agentic AI in 2025–26
up to 80%
efficiency gain reported for agentic MedDRA coding
Industry figures, not Merakee client results.
WHERE AI EARNS ITS PLACE

Six workflows we automate, and one we won't.

Case processing is the cost centre. Signal work is the risk. Both respond well to automation — medical judgment does not, and we will tell you where to stop.

Automated case intake
NLP pulls reporter, patient, product, and event details out of email, PDFs, and intake portals, then triages by seriousness before a human opens the case.
MedDRA coding support
Agent-proposed codes arrive with a confidence score and the rationale behind them. Your coders confirm — nothing commits silently.
Signal triage & living assessments
Agents watch FDA and EudraVigilance adverse event data, literature, and your own safety data continuously, and refresh the assessment when new evidence lands.
Literature surveillance
Automated screening and de-duplication across databases, with an audit trail behind every include and exclude decision.
Aggregate report drafting
First-pass PBRER, PSUR, and DSUR narratives generated from validated data, formatted and ready for medical review.
Custom PV apps & agents
Internal tools, workflow apps, and dashboards built around how your team actually works — not another platform licence to buy.
VALIDATED BY DESIGN

The AI is the easy part. The evidence is the job.

We came to AI through computer system validation, not the other way around. Every model we deploy arrives with the same documentation trail we'd hand an auditor for an Argus upgrade — because sooner or later, someone will ask for it.

Talk through your validation approach
GxP validation evidence
IQ/OQ/PQ, traceability matrix, and executed test scripts for every model we put into your environment.
Explainable by default
Every output carries its rationale and source record. Black-box classifications are not fit for regulatory use.
Human in the loop
AI drafts, your reviewers decide. Causality and seriousness assessments stay with qualified people.
Aligned to the frameworks
CIOMS WG XIV, GVP Module IX, ICH E2B(R3), and EU AI Act expectations built into the design, not bolted on after.
OTHER SERVICES
Safety Systems Consulting
Data Analytics & Visualization
Data Migration
CSV Consulting

Curious what AI could actually take off your plate?

We will walk your workflows with you and say plainly which ones are worth automating — and which are not.

Get in touch
Merakee BI

Dedicated PV consulting for safety systems, analytics, migration, and AI development.

CONTACT
600 Matheson Blvd W Unit 5, Mississauga, ON L5R 4C1, Canada
647-854-1079
info@merakeebi.com
© 2020–2026 Merakee BI Analytics Ltd.Mississauga, Ontario, Canada
AI DEVELOPMENT

Agentic AI for drug safety, built to pass validation.

Most PV teams don't need another AI platform. They need someone who knows both the safety database and the model — and can put the two together with evidence an inspector will accept. That's what we build.

WHY NOW
~⅔
of a typical PV budget is consumed by case processing alone
73%
of pharma organizations are planning or deploying agentic AI in 2025–26
up to 80%
efficiency gain reported for agentic MedDRA coding
Industry figures, not Merakee client results.
WHERE AI EARNS ITS PLACE

Six workflows we automate, and one we won't.

Case processing is the cost centre. Signal work is the risk. Both respond well to automation — medical judgment does not, and we will tell you where to stop.

Automated case intake
NLP pulls reporter, patient, product, and event details out of email, PDFs, and intake portals, then triages by seriousness before a human opens the case.
MedDRA coding support
Agent-proposed codes arrive with a confidence score and the rationale behind them. Your coders confirm — nothing commits silently.
Signal triage & living assessments
Agents watch FDA and EudraVigilance adverse event data, literature, and your own safety data continuously, and refresh the assessment when new evidence lands.
Literature surveillance
Automated screening and de-duplication across databases, with an audit trail behind every include and exclude decision.
Aggregate report drafting
First-pass PBRER, PSUR, and DSUR narratives generated from validated data, formatted and ready for medical review.
Custom PV apps & agents
Internal tools, workflow apps, and dashboards built around how your team actually works — not another platform licence to buy.
VALIDATED BY DESIGN

The AI is the easy part. The evidence is the job.

We came to AI through computer system validation, not the other way around. Every model we deploy arrives with the same documentation trail we'd hand an auditor for an Argus upgrade — because sooner or later, someone will ask for it.

Talk through your validation approach
GxP validation evidence
IQ/OQ/PQ, traceability matrix, and executed test scripts for every model we put into your environment.
Explainable by default
Every output carries its rationale and source record. Black-box classifications are not fit for regulatory use.
Human in the loop
AI drafts, your reviewers decide. Causality and seriousness assessments stay with qualified people.
Aligned to the frameworks
CIOMS WG XIV, GVP Module IX, ICH E2B(R3), and EU AI Act expectations built into the design, not bolted on after.
OTHER SERVICES
Safety Systems Consulting
Data Analytics & Visualization
Data Migration
CSV Consulting

Curious what AI could actually take off your plate?

We will walk your workflows with you and say plainly which ones are worth automating — and which are not.

Get in touch
Merakee BI

Dedicated PV consulting for safety systems, analytics, migration, and AI development.

CONTACT
600 Matheson Blvd W Unit 5, Mississauga, ON L5R 4C1, Canada
647-854-1079
info@merakeebi.com
© 2020–2026 Merakee BI Analytics Ltd.Mississauga, Ontario, Canada