REGULATORY CORRESPONDENCE

The clock starts when the query lands. So should the evidence.

A health authority question arrives as unstructured text, and answering it means reasoning across thousands of documents nobody has time to reread. We parse the query on arrival, name the source sections it points to, and put an evidence package in your reviewer's hands the same day. Every claim in it carries the page it came from.

25 years in regulated industries

Life sciences, insurance, energy, financial services.

Runs in your environment

Bring your own model. No regulated content leaves your tenancy.

Evidence, not extraction

Every value keeps its link to file, page and version.

Sits under your system of record

Your RIM, eTMF and submission platform stay where they are.

See it run on a real claim

Click through it at your own pace. No form, no sign-up.

See the POV Program ▸

Your own correspondence documents. An implementation engineer assigned to you.

A day with one information request

Same query. Same team. Different day.

Today

8:10The query lands in a shared mailbox. Someone reads it and forwards it.
9:30Two people argue about which SME owns the answer.
11:00The search for supporting sections begins. Three systems, one person's memory.
14:00A draft goes to an SME with a link to a folder and a note saying it's in there somewhere.
16:30The SME spends the afternoon locating context, not applying judgment.
Day 9QC finds a number in the draft that nobody can trace back to a source page.

Two weeks gone before the first real regulatory decision gets made.

With Adlib

8:10The query is parsed on arrival. Type classified, deadline logged, commitments extracted.
8:20Source sections named. Relevant excerpts retrieved and assembled.
8:30The right reviewer opens a package with the excerpts and the real due date already in it.
10:00Draft response generated, every claim carrying its source section inline.
11:15The SME reviews side by side and dispositions: approve, revise, or needs analysis.
Day 2QC checks every figure against its source. The commitment is registered and tracked to closure.

Your regulatory people spend the two weeks on regulatory strategy.

Illustrative. Timings describe the workflow, not a measured customer result.

How It Works

Three things happen before your SME opens the query

01

Understood

The query is classified, the underlying concept extracted, the response deadline logged, and any commitment buried in the text pulled out as a tracked item.

02

Routed

Source sections are identified and the excerpts retrieved, so the package reaching an SME already holds the evidence and the real due date.

03

Evidenced

Every figure stays linked to its file, page and version, plus who checked it and when, from intake through to closure.

Agents assemble the evidence. Your people still decide and sign.

What a reviewer opens

One information request, unpacked.

ArrivedHealth authority information request, email attachment, 8:07
Classified asClinical safety query, response window 30 days, logged
Concept extractedCytokine release syndrome, severity grading and reporting consistency
Source sections namedModule 2.5 clinical overview, Module 2.7.4 summary of clinical safety
Routed toClinical safety reviewer, with excerpts and the statistical table attached
Draft carriesOne paragraph, every figure cited inline to its source page and version
QC verifiedFigures traced to source, terminology consistent, no understatement of severity
Left behindA commitment register entry, a deadline alert, and a precedent the next query finds automatically

Illustrative example. Not drawn from customer correspondence.

Fits your environment

It sits under what you already run.

Your RIM stays your RIM. Your submission platform stays your submission platform. This is the layer underneath them, where documents get validated and evidence-anchored before anything lands in a system of record.

That also means a platform migration changes where your documents live, not how they are governed.

Where your team works

RIM
eTMF
Submission publishing
AI assistants

Adlib evidence layer

Validated, classified, evidence-anchored. Bring your own model.

Classify
Validate
Anchor to source

Where documents actually come from

Health authority correspondence
Shared mailboxes
CRO and partner portals
Legacy repositories and drives

Deploys in your environment or hosted, with the same controls either way. The audit trail starts at intake, not where a pipeline happened to be instrumented.

Who this is for

Three rooms where this lands.

Regulatory affairs leaders

You are answering across multiple health authorities at volume. Deadlines slip because of the volume, not because of effort. The people who should be doing regulatory strategy are reconciling documents.

Regulatory operations and RIM owners

You own the commitment register, the deadline tracking and the audit trail. You need the answer to "what did we promise, and where is it" to be a lookup rather than an archaeology project.

IT and regulatory technology

The business is evaluating AI tools without you, and you carry the risk when one enters a validated environment. You want the next AI request to be a configuration conversation, not a new qualification project.

Proof of value

Run it on correspondence you have already answered.

You already know what the right response looked like, how long it took, and how many people it pulled in. That makes your closed correspondence the fairest test set there is, and the only one where the answer key already exists.

First

You pick the queries

Three to five information requests you have already closed. You choose them, including the one that went badly.

Then

We walk the prototype through them

A working session with your team. Classification, source sections, routing package, cited draft, QC trail. Side by side with what your team actually produced.

Not

A paid engagement, or a procurement event

No fee, no production access, no new vendor onboarding. A couple of hours from one SME and a session with regulatory and IT in the same room.

This capability is in active development with design partners shaping it. If you want the workflow built around how your team actually answers, this is the point in the cycle where that is still possible.

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Questions

FAQ

Does this replace our RIM or submission platform?

No. It sits underneath them. Documents are validated and evidence-anchored before anything reaches your system of record, which is a different job from storing and publishing them.

We already use GenAI for drafting. How is this different?

We are not competing with the model. A fluent draft that cannot point to the section it came from does not survive review, and that failure comes from ungoverned input rather than from the model. We govern the input and keep the citation attached.

Does our content leave our environment?

Deployment is your choice, in your environment or hosted, with the same controls either way. Bring your own model.

What does the walkthrough cost, and what does it need from us?

Nothing, and roughly two hours from one SME plus a session with regulatory and IT together. It is not a paid proof of concept and there is no obligation attached to it.

Is this generally available?

Not yet. The correspondence capability is in active development, which is exactly why a walkthrough on your own closed queries is useful now rather than after the fact.

How is this different from the OCR and IDP tools we already have?

Extraction pulls values out. Traceability keeps each one connected to the source page, field and version it came from, through review, QC and closure. The second one is what an inspection asks for.