Right now, pharma teams spend months writing and checking regulatory documents by hand.
We are building software that does the heavy lifting. It drafts the documents your team needs, like Clinical Study Reports, CAPAs, deviations and submission dossiers, then checks each one against the actual FDA, EMA and ICH rules before anyone reviews it. Most teams are up and running in a few weeks.
Built to meet the rules you answer to tap any one to see how
How it works
The checking step is where things slip. People are busy, the older tools miss things, and documents that should not pass end up passing. That is how companies end up with FDA observations and warning letters. We run that check automatically against the real rules, so problems show up early instead of in an inspection. And we keep the rules current, so your team does not have to.
A document gets drafted
A study report, a CAPA, a deviation, a dossier section
We check it automatically
Against the FDA, EMA and ICH rules that apply to it
Anything off gets flagged
Caught before sign-off, not during an inspection
What we focus on
We get teams live in a few weeks. These projects usually drag on for many months before anyone sees value.
Live in weeksWe check each document against the rules that apply to it before anyone reviews it, so problems are caught early.
Caught before sign-offWe price it so a growing pharma or biotech can actually afford it, not just the largest players in the market.
$50K to $100K a yearWhy it matters
In pharma, getting to market sooner is real money. Every month we help you file faster, safely and by the book, is another month your product is approved and earning. The speed only counts because the compliance is right, and that is exactly what we are building.
There are thousands of small and mid-size pharma companies, roughly 5,000 to 8,000, who need this today and have nowhere good to turn.
Get in touch
If you would like to learn more, or just be in touch, email me directly and I will get back to you.
issamaarida@gmail.com