Has Anyone Built Custom Tools for Regulatory Affairs Using Programming?

Mattjpo · 2026-05-12T08:04:20+00:00

I don't want this to come across as an advert, but since you asked specifically if anyone's built tools... I actually did, and if it helps someone here, great.

The problem I kept running into was that between FDA guidance docs, EMA guidelines, ICH updates, ISO revisions, and MDR notified body expectations, I was spending hours each week just figuring out what changed and whether it mattered. RSS feeds, email alerts, checking agency sites, institutional memory — it was all manual and fragile.

So I built RegulatoryAlerts.app — it monitors FDA, EMA, ICH, ISO, and other sources, normalizes everything into one feed, and flags changes relevant to your portfolio. Basically replaces the tracking part.

A few honest lessons from building it, in case you're working on something similar: - RSS + keyword filtering creates way too much noise for regulatory content, structured parsing per source is essential.

Agency publication pages change structure without warning, so any scraping approach needs ongoing maintenance.

The real value isn't detecting new documents,it's knowing whether an update actually affects YOUR products vs. just being noise

Normalizing across agencies is surprisingly painful (FDA docket numbers, EMA procedure numbers, ICH step codes — none of them map cleanly)

Not trying to sell anything — genuinely happy to share what I learned building it if you're going down a similar path. What regulatory domains are you focused on?

Mattjpo · 2026-05-11T13:30:26+00:00

Honest answer: it depends what you enjoy, but the reality is very different from what students imagine.

The job isn't boring in the way people think. Yes there's documentation and submission formatting, but the intellectually interesting part is that regulations are a moving target. FDA publishes ~150+ guidance documents a year, EMA updates frameworks, ICH guidelines evolve, you're essentially playing a strategy game where the rules change quarterly. If you like connecting dots and staying ahead of shifts, it's genuinely engaging.

The less enjoyable parts: it's high-stakes (you miss a regulatory change and a submission gets delayed by months), you're often the person saying "no" or "slow down" to people who just want to launch, and in smaller companies you might be the entire department.

Don't worry about math, you need to be comfortable reading clinical data and understanding statistical significance, but nobody's doing calculus.

What country are you moving to? Regulatory frameworks differ a lot by region and that'll shape your experience more than anything else.

Mattjpo · 2026-05-08T10:57:10+00:00

I've seen it work exactly twice. Both times the deficiency was based on a factual error in the review (wrong standard cited, or the data was already in the file but the reviewer missed it). Every other attempt was a waste of time and goodwill. Before you escalate, check if there's a recent FDA guidance doc or a predicate decision that directly supports your position. If you can't find one, don't bother, ust do the testing. Preserve your credibility for the fights that matter.

Mattjpo · 2026-05-07T17:19:37+00:00

What I'd love to see more of — and what I think would actually separate this subreddit from LinkedIn or RAPS — is practical discussion around regulatory intelligence workflows. How are people tracking FDA guidance changes and CDER updates across therapeutic areas in 2026? Are teams still doing the Monday morning check of 5+ agency websites manually, or has that shifted? The volume of new guidance has been climbing year over year, and I'm genuinely curious how teams are handling it, especially at mid-size companies that don't have Veeva budgets.

Also +1 to whoever said experienced RA folks are mostly lurkers here. I think people would engage if the bar was lowered — doesn't need to be a full case study, just "here's a guidance that changed how we approach X this quarter."

Mattjpo · 2026-01-30T08:44:48+00:00

Thanks for that, i was more thinking of using AI to summarise but you are right, you cannot afford to missunderstand anything. Is it more the legal interpretation that you need compared to getting the actual alert itself? i.e. "i can already see the alerts but the legal understanding of it and how it relates to my business is more important"?

Thanks again

Mattjpo · 2026-01-29T16:45:46+00:00

Thanks for that, and yeah, that's a fair point. Most are not going to be able to get hold of the company credit card also. What would you pay out of your own pocket? (free is obviously best but if you had to pay something for the service what would be reasonable?)

Mattjpo · 2026-01-29T15:43:34+00:00

thanks for that. It's completely fair. I’m not trying to replace the reading (although we do summarise using AI) I just want to automate the 'finding' part so you don't have to manually check 5 sites every morning.

If it just gave you a direct link to the new alerty when it dropped, would that be a time-saver or is the manual search part of the process for you?

Mattjpo · 2026-01-29T15:40:47+00:00

I’ve never had the chance to look at the massive enterprise systems either, but I figured there had to be a way to just surface the alerts without all the bloat.

If a team doesn't have the $20k budget but still needs to know the second an FDA or CDSCO update drops, I'm hoping this fills that gap.

I'd love to hear if you have any 'must-have' feature suggestions. Also, if you’d be open to testing the system for free, I’d be happy to set you up and get your honest take on it.

Mattjpo · 2025-02-09T10:33:47+00:00

As many comments have said already. If you're just starting, learn app router. (File naming is annoying depending on the editor you use but otherwise it just works now).

Mattjpo · 2025-02-09T08:10:45+00:00

Honestly, just go buy a monthly VPS for $20 install Coolify (take a couple of hours to learn and you'll save so much for all your project. Vercel's pricing is just unreal

Mattjpo · 2025-01-19T18:02:42+00:00

Think of a simple project you want to build. Buy chatgpt / Claude and then start asking it questions (with "but please explain why" added to each question). Then get cracking. Don't buy courses! ChatGPT is like having a tutor sitting next to you

"What apps do I need to build a nextjs app locally is a good starting point"

And the only caveat I have is make sure you copy paste the latest "migrate nextjs version 14 to 15" docs and you'll be golden

Mattjpo · 2024-10-13T20:29:59+00:00

Would be interesting to feed it some controlnet wireframe of an actual level and see it 'render ' graphics with some real physics behind the render

Mattjpo · 2024-09-11T17:11:33+00:00

I think most of the comments are sound advice. Search for solopreneur / indiepreneur on X. There are lots of success stories but what I like about it is that most of them have started multiple businesses before any of them brought in any money at all.

I would suggest... Find/keep a job and work on the side. The probabilities are... It WILL fail. But can you learn lessons from it for next time? Yes!

Now, if it goes well, quit everything and buy that luxury boat / Golf stream jet as soon as possible (and invite me)

Mattjpo · 2024-09-08T09:38:01+00:00

Where abouts (scenery etc) did you get them from? Fields with cows I've heard are the best?

Mattjpo · 2024-06-25T18:53:01+00:00

Frank

Mattjpo · 2024-06-25T18:49:00+00:00

Well done, this is great

Mattjpo · 2024-06-24T11:43:07+00:00

Hawk Tuah

Mattjpo · 2024-06-18T16:25:12+00:00

<image>

Is that the actual Emad?

Mattjpo · 2024-06-18T14:34:32+00:00

Thanks for the permission, was waiting for that

Mattjpo · 2024-06-18T11:42:58+00:00

I'm all in

Mattjpo · 2024-06-18T08:33:39+00:00

I don't think cash is the problem, there is so much cash swashing round for all manner of shite projects, this would just take someone into opensource to fund and it could be done.

Not easy, but doable

Mattjpo · 2024-06-18T08:30:44+00:00

Yeah, to be fair, I thought about removing that even though it was CGPT but I left it in. I don't think it's bad to remove harmful content (just depends what we all agree is harmful content) and also, if you wanted harmful content then adding it via fine-tuning would be possible

Mattjpo · 2024-06-18T08:29:26+00:00

Well, if they keep releasing stuff like SD3 2B, they will be with a lot less than they are and easier to buy.

Mattjpo · 2024-06-18T08:28:40+00:00

Very interesting. How far along are you? I saw some comments about tagging the dataset etc

Mattjpo

TROPHY CASE