Frequently asked questions

Approve Suite is an AI regulatory platform for biotech quality and regulatory teams. It reads public FDA, SEC and ClinicalTrials.gov records on a schedule, summarizes each new record and says why it matters, matches it against the companies, indications, CFR parts and GxP areas on your watchlist, and delivers the matches in one daily email, with instant alerts for critical items. Ask AI answers your questions about any company, trial or regulation from the same records and cites the events it used. Every item links to its primary source. It is informational, not regulatory, legal or medical advice.

Heads of quality and regulatory affairs at clinical-stage biotechs that outsource manufacturing to CDMOs and trials to CROs, and business development at the CDMOs, CROs, consultancies and vendors who sell to them and want to know who was just inspected, funded or approved. It is not built for large pharma quality organizations, for multi-country registration requirements, or for anyone who needs the text of Form 483s.

The free plan shows the last 7 days of records with filters and analytics, the company explorer and profiles, 3 Ask AI questions, and a weekly industry top-5 email. No card is required. Pro is $79 a month or $790 a year and adds your own watchlist, a daily digest at your hour, instant email alerts on critical events, the full archive, saved views, and Ask AI at 40 questions a day. You can cancel anytime.

No. Every item is a public fact with a link to the source and a one-line explanation of why it matched your watchlist. Decisions are yours.

Most records are checked every two to six hours; the ones agencies update once a day are read once a day. Critical items that match your watchlist go out within fifteen minutes of arriving. The daily digest goes out at the hour you pick.

The FDA does not publish most 483s; they are released through FOIA. We deliver what is public: the inspection's classification, the CFR sections it cited, and any warning letter that follows.

FDA's email lists send everything from one office with no company filter, and the SEC, ClinicalTrials.gov and the eCFR each have their own. Approve Suite merges them into one feed, resolves each company's names across them (the name FDA uses, the ClinicalTrials.gov sponsor name, the SEC filer), matches records to your watchlist, explains why each one matters, and maps CFR changes to their GxP area and the guidances that cite them.

Ask AI answers questions about FDA actions, trials, companies, filings and the regulations behind them using only the data in the product, and cites the events it used. Free accounts get 3 questions to try it; Pro accounts get 40 a day. Questions outside the life-science industry are declined. Answers are information, not advice.

Open Watchlist and type the name. Companies are matched to their ClinicalTrials.gov sponsor names and SEC filings for you, so a subsidiary or an old name still matches.

Open the event in the dashboard: it shows which watchlist rules it matched, or didn't. Most misses are a missing company alias or a severity threshold.

Not yet. Today it covers United States records only. EMA is on the roadmap.

No. Approve Suite is an independent product of Catalyst Collective, LLC. It reads records that the FDA, the SEC and the National Library of Medicine publish and is not affiliated with, endorsed by, or operated on behalf of any agency.

No. Free has no card and no time limit. Upgrade when you want a watchlist.

The free plan is the trial. Pro starts when you subscribe, and you can cancel anytime.

$79 a month, or $790 a year (two months free). 1 seat, 1 watchlist.

We charge your card monthly or yearly, and your plan renews until you cancel. Receipts, card changes and cancellation are in the billing portal on your profile page.

Yes, from your profile. Pro runs to the end of the period you paid for, then your account drops to Free. No refunds for partial periods.

Team plans are by email: info@approvesuite.com.