In development
Generic drug filings
are still written by hand.
Regulark is building the software that writes them: it researches the reference drug, finds the correct wording, and drafts each ANDA section with FDA's annotations and vocabulary, while a named person on the regulatory team approves every change.
The problem.
Generic drugs carry most of America's prescriptions. Every one of them reaches patients through an ANDA, and a large part of every ANDA is careful, repetitive writing.
new ANDAs were filed with FDA in fiscal 2025.
Each one carries its own labeling and regional documents.
Source: FDA statisticspages in a typical prescribing label.
Every word has to be accounted for in the generic version.
the same as the labeling of the reference listed drug except for differences annotated and explainedWhat US law requires of every generic label, 21 CFR 314.94(a)(8)
Word for word, by hand.
Regulatory teams copy the reference label, change what the law allows, and write a reason for every difference, mostly in Word.
One miss can cost months.
A protected use left in, or a cross-reference left pointing at removed text, can draw an FDA deficiency and delay approval.
It never stays done.
Every time the brand label changes, every generic that follows it has to be updated and re-annotated.
Our solution.
Software does the volume. People keep the judgment. Scroll to see how one section is made.
Research
Regulark gathers what the section depends on: the reference label, Orange Book patents and exclusivities, and FDA's product-specific guidance.
Draft
It writes the section in FDA's vocabulary. Every sentence is traced back to the source it came from.
Annotate
Differences from the reference drug are marked and numbered, each with its reason, the way the annotated comparison is laid out.
Approve and record
A named person on your team approves each change. Every decision is chained into a record that shows if it's ever altered.
Your whole ANDA.
Starting with Module 1.
We start where the writing is most repetitive and the rules are most exact: the regional section and its labeling. Then we carry on through the rest of the dossier.
Module 1, where we start. The US regional section: cover letter, basis for submission, the bioavailability waiver request, and the labeling, including the annotated comparison with the reference drug.
Module 2. Summaries of the information in Modules 3 to 5, written to a fixed structure.
Module 3. Quality: the drug substance, the finished product, and how they are made and tested.
Module 4. Nonclinical study reports, where a filing needs them.
Module 5. Clinical study reports. For a generic, mainly the bioequivalence studies showing it matches the reference drug.
The value we create.
For the generic manufacturer's regulatory team.
Less time drafting Module 1.
Our target, to be measured against an experienced specialist's hours per section.
Fewer deficiencies.
Every difference from the reference drug is found, marked and given a reason, so nothing is silently dropped.
A record you can hand to QA.
Who approved each change, when, and on what source, in a chain that shows if it was ever altered.
Specialists stop retyping and spend their time on the decisions only they can make.
The value we capture.
How Regulark plans to earn.
Priced per filing.
Customers pay for the sections and filings we produce, not for seats. Price follows the work saved.
Recurring by nature.
Each brand label change sends work to every generic that follows it, so a customer's portfolio keeps generating updates.
Land and expand.
Start with labeling, grow across Module 1, then into Modules 2 to 5 of the same filings.
Why now.
Models can finally draft.
Language models can now write regulatory text to a standard worth reviewing. Regulark uses Claude to draft every proposed change.
Regulators want people in charge.
The joint FDA and EMA principles for AI in drug development (January 2026) put human oversight and clear accountability first. That is how Regulark is built.
Generics have been overlooked.
Most AI for regulatory writing targets new-drug submissions. The generic filing, with its exact rules and constant updates, has been largely left alone.
See it on a drug
you file against.
We'll walk your regulatory team through a filing section, built from a reference listed drug of your choice.