AI regulatory intelligence that checks every new guidance against your file.
Brief Mark, Gary and Fiona once. They read what the agencies publish, compare it with your labels and reports, and draft the impact note overnight. By morning it's on your phone, every line cited and nothing sent.
Tuesday morning
7:02
Your overnight work is ready
Fiona's impact note is held for you. 1 clash and 1 line Gary couldn't confirm need a look.
AL-204 label, in-use shelf life
When this earns its keep
- An agency publishes on Friday night
- By Monday someone has to say whether it touches your products. Now the answer is ready before they ask.
- You follow more agencies than you can read
- Each market has its own publications. Mark can follow the ones you name and stay quiet until something matters.
- The answer is somewhere in the file
- Reports, letters and superseded versions pile up. Gary finds the current one and shows you where it is.
- A wrong line gets expensive
- You can't accept a summary with no source. Here each line opens the page it came from, and a gap stays marked as a gap.
One night for pharma and regulatory teams.
9:40 pm
You brief, then close the laptop.
"A new draft guidance on in-use shelf life came out today. Check it against the AL-204 label and our stability reports, tell me what has to change, and draft an impact note for the team."
11:15 pm
Mark reads the guidance.
He tags each requirement to its section. Section 4.3 wants stability data behind any in-use shelf life on the label. Your label says 28 days after opening.
2:30 am
Gary digs through the file.
He reads 126 documents, drops the 19 superseded versions and ranks the 4 that matter. One record about the second site can't be confirmed, so he flags it and leaves it open.
4:50 am
Fiona drafts. Mark checks her work.
She drafts the label wording and the impact note. Mark checks both against the sources, then the note locks as Held. Not sent.
7:02 am
Your phone buzzes.
A short summary, and the two things that need you. The rest is done.
This is your morning. Try it.
It's the phone screen you'd open at 7:02. Nothing here is a screenshot, so go ahead and tap.
- Tap any line to open its source.
- Read the two flagged lines.
- Edit the draft if you like, then approve it.
Tuesday, 7:02 am
AL-204 label, in-use shelf life
The draft guidance touches one label statement. Impact note and proposed wording are ready and held for you.
Impact note to the AL-204 team
Held. Not sentDraft guidance section 4.3 means our 28-day in-use statement needs data we don't have. SR-118 supports 21 days. I propose changing the label to 21. Quality should confirm whether Site B data covers the 50 mL pack before we file.
Example only. The product, the guidance and the reports are invented to show how it works.
Your three associates.
They hand work to each other and check each other. Here's what each one does for you.
Mark reads.
Reads new guidance as it's published, tags each requirement to its section, and flags clashes with your labels and files.
Gary digs.
Mass-reads reports, letters and past submissions, drops superseded versions and ranks the few that matter.
Fiona drafts.
Drafts impact notes and label wording. Mark cross-checks them, then they lock as Held. Not sent.
Five briefs to start with.
Pick the one closest to your week. Each is written the way you'd brief a colleague.
Guidance watchYou follow agencies across markets and don't want to check each one daily.
Every night, watch FDA and EMA for new guidance on stability and labeling. When something appears, check it against our approved labels and tell me only if something clashes.
By morningQuiet most days. When something's published, a short push with the requirement and the source.
Labeling gap assessmentA new requirement or a reference label changed.
Compare our current label with the attached reference label, section by section. List every difference, say whether our file supports a change, and draft proposed wording.
By morningA section-by-section list with sources on both sides, and held wording for your review.
Impact assessmentA change is proposed and you need to know what it touches.
We're moving this product to a new pack size. Go through the file and list every document, commitment and market that this affects. Draft an impact note for the team.
By morningA list of what's affected with page references, and anything the file can't confirm.
Agency question responseA question came back and the clock has started.
The agency asked the attached question on our specification. Find everything in our file that bears on it, plus any past answers we've given, and draft a response.
By morningA held draft with every statement cited to your own documents.
Weekly literature sweepYou need published papers on your product read on a schedule.
Every week, sweep new publications that mention our product or its class. Summarize anything that may matter for safety and link each point to the paper. Your safety team decides what counts as a case.
By morningA cited shortlist for your safety team to review. Nothing is classified for them.
How to write a good brief.
Four sentences is enough. Say what you'd tell a colleague before leaving for the day.
The job
Check the new draft guidance on in-use shelf life against the AL-204 label.
One clear job, as you'd say it to a colleague at their desk.
What to read
Use the guidance published today, the approved label and our stability reports.
Name the sources. Anything else gets flagged, not assumed.
What matters
I care about anything that forces a label change or a filing.
This tells Gary how to rank what he finds.
What you want back
Draft a one-page impact note for the team, with proposed wording.
Fiona drafts to this, and it waits for you.
What it won't do.
- It doesn't sign off anything. Your qualified people still do.
- It doesn't file or send anything without your yes.
- It doesn't fill gaps with a guess. If a record can't be found, you'll see that plainly.
- It doesn't make safety or quality decisions. It gives your team cited material to decide from.
Questions you might have.
What is AI regulatory intelligence?
It's AI that follows what regulators publish and works out what it means for your products. Corrente reads new guidance, compares it with your labels and reports, and tells you what changes, with a source on every line.
Which agencies can it follow?
You tell it which sources to follow in your brief, such as FDA or EMA guidance. Coverage of each agency will be confirmed at launch.
Can it run a labeling gap assessment?
Yes. Brief it with your label and the reference, and it compares them section by section, says what your file supports, and drafts wording for your review.
Does it replace our regulatory or quality review?
No. It does the reading and the first draft. Your people review, decide and sign off, and nothing goes out until someone says yes.
What happens when it can't find a source?
It marks the line as couldn't confirm and tells you what it looked for. It doesn't guess.
Do my team need technical skills?
No. You write the brief in plain English and review the work on your phone.
Brief once. They keep going.
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