Regulatory intelligence software that tells each team what an agency change means for its products
Every agency change reaches the right team within hours, with what changed marked.
See one case, screen by screen ↓Software that watches health authorities for new and changed guidance, regulations and safety communications and tells regulatory affairs what each one means for its products. Regulatory Intelligence adds seven agents that check 64 sources every morning, translate, summarize with citations, compare revised documents with the versions they replace and propose the impact per product, for a regulatory lead to confirm and sign.
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Regulatory teams read hundreds of agency pages a week in a dozen languages: FDA guidance and Federal Register notices, EMA guidelines and CHMP outcomes, PMDA and MHLW notices in Japanese, NMPA announcements in Chinese, ANVISA resolutions in Portuguese. Most of it arrives as PDFs, found through bookmarks, email alerts and newsletters, then copied into a spreadsheet.
A revised guideline rarely says what it changed. Someone puts the draft beside the version it replaces and compares them by hand, the finding lives in an email, and the product regulatory lead hears about it a week later. A notice in Japanese waits for translation while its deadline runs. Miss one paragraph and a variation goes in without the data the assessor now expects.
Estimated split for one update, by hand and with the solution. The totals match the median on the working solution's dashboard: 7.6 days by hand in 2025, 3.4 hours with the agents.
Seven specialist agents watch, translate, compare versions and assess every update; a regulatory lead signs the impact.
Tuesday 6 October 2026. Overnight, EMA published a revised drug–device quality guideline for consultation, and PMDA, FDA and NMPA all issued something that touches the portfolio — Veltrimab, Talmirex, Corventa and Lumora. Here is what happens next, screen by screen, in the working solution.
The agency watcher checks 64 sources in 38 countries and finds 41 changed pages — 27 new updates once duplicates are removed. The translator renders 9 documents from Japanese, Chinese, German and Portuguese, originals kept. The version comparer checks 3 revised documents against the versions they replace: 22 changed paragraphs, 5 of which change a plan. The impact assessor proposes 5 High, 8 Medium, 10 Low and 4 not relevant.
“Chose the lead: highest impact on your products — EMA drug–device draft · Veltrimab autoinjector.” 05:12
Edition No. 214 printed at 05:12 CET: 27 updates, 9 agencies, 64 sources checked. The lead story is EMA's draft Revision 1 of the drug–device quality guideline, which puts the Veltrimab autoinjector switch in scope. Beside it: one labeling format change for Veltrimab with two deadlines on 1 December, the deadlines in this edition, and 13 High and Medium impacts waiting for a signature. Below, a column each for FDA, EMA, PMDA / MHLW, NMPA and MHRA.
“High and Medium impacts. Teams are told only after a lead signs.”
Against the 2019 guideline in force, 11 paragraphs changed: 6 editorial, 3 need a check, 2 change your plans. §4.2 is rewritten — a variation that changes the device part of an integral product now needs comparability data and a Notified Body Opinion; that lands on Lena Ortiz in Biologics regulatory. §4.3 is new — moving from prefilled syringe to autoinjector needs delivered-dose, dose-accuracy and injection-time comparability on three batches; that lands on Tom Becker in Device engineering.
The version comparer compares against the version the agency names as replaced, never a guess, and shows the old and new wording word for word.
The plan view shows three new steps for the Veltrimab autoinjector EU variation: book the notified body, the notified body opinion, and two more delivered-dose batches from December to February. Filing stays in May 2027 only if the notified body is booked by 30 October. Dana confirms the autoinjector as High and the prefilled syringe as Medium, leaves the three teams ticked to be notified and signs: “I confirm this impact assessment”.
“Signed electronically as Dana Okafor — your name, date, time and meaning go on the audit trail.”
The impact is confirmed by Dana Okafor at 09:14 on 6 October 2026. Biologics regulatory gets §4.2, Device engineering gets §4.3, §5.3 and §6, and Regulatory policy gets §8, each note with the original document attached. Nothing was sent before the signature.
“Impact confirmed · Biologics regulatory, Device engineering and Regulatory policy notified”
MHLW notice 医薬薬審1002第3号 puts veltrimab in the first wave of XML format 2.0 for electronic package inserts: every section goes into structured fields, and the re-issued insert must be on the PMDA website by 1 December 2026. Each paragraph of the original sits next to its English translation, and each summary line links to its passage. The impact assessor proposes High for Japan, 95% confident.
“The Japan label update is planned for the February 2027 cycle (labeling plan row JP-14). The notice requires posting by 1 Dec 2026 — about 10 weeks earlier.”
The assistant searches 4,812 updates and 3 internal plans, reads the notice in Japanese and checks the labeling plan. Yes: it moves the Japan label update for Veltrimab forward by about 10 weeks, and the EU asks for the same product information in the ePI standard, also due 1 December. The sources open beside the answer — the Japanese passage highlighted with its translation, and row JP-14 of the labeling plan.
“Next step: open a Japan label change now and add the wording to the core data sheet, so both markets move together.”
The rest of the edition is one list: 5 High, 8 Medium, 10 Low, 4 not relevant, filterable by agency and product and searchable in any language. Translated titles keep the original beside them. Each row carries its deadline — comments close on the EMA draft in 117 days, the FDA stent draft's comments are due 31 December.
The impact board lays the open impacts out by product and agency, then by stage: 13 new and waiting for confirmation, 3 assessed with teams working, 4 actioned. Corventa carries three FDA impacts, led by the revised stent draft that asks for five years of follow-up where the PMA supplement plans three. Fourteen Low and Not relevant updates were filed automatically today.
The dashboard shows 3,977 updates read in 2026 from 64 sources in 38 countries, and a median of 3.4 hours from publication to the owning team, against 7.6 days by hand in 2025. 714 High and Medium impacts were confirmed this year, each signed by a named lead; 96% were confirmed within 2 working days, and the agent's proposed impact was kept 91% of the time.
“Every High and Medium impact in 2026 was confirmed by a named lead before teams were notified.”
The same morning, seen by the five people it reaches — what their week looked like, and what it looks like now.
Seven specialist agents watch, translate, compare versions and assess every update; a regulatory lead signs the impact.
Checks 64 agency sources every morning from 05:00 CET and collects anything new or changed — guidance, notices, regulations, safety communications — keeping the original file, its address and publication date, and dropping duplicates.
Translates Japanese, Chinese, German, Portuguese, French, Korean and more into English, paragraph by paragraph, with the original side by side.
Writes three to five plain lines per update — what changed, for which products or devices, and by when — and records the key dates: published, comments close, effective.
When a guideline is revised, finds the version it replaces and compares them paragraph by paragraph — rewritten, new, widened or editorial — and names the team and plan each change lands on.
Compares each update with every product and market licence in the portfolio register, the labeling plan and the submission calendar, and proposes High, Medium, Low or Not relevant per product, with the reason and its confidence.
Lays out the morning front page, led by the update with the highest impact on your products, and sends each team its note in its own language once a lead confirms.
Answers questions in any language across all updates and internal plans, citing the exact page for every statement — with the original passage and its translation when the source is not in English.
Confirms each impact. The agents propose; a named person decides.
Ask in any language, and choose an answer in English, Japanese, Chinese or German. Answers come from 4,812 agency updates and your internal plans — every line links to the exact page, with the original text and a translation.
Does the new PMDA notice change our labeling timeline?
Yes — it moves the Japan label update for Veltrimab forward by about 10 weeks. The notice puts veltrimab in the first wave of XML format 2.0, and the re-issued electronic package insert must be on the PMDA website by 1 December 2026. Your labeling plan puts this update in the February 2027 cycle, and the EU asks for the same product information in the ePI standard, also due 1 December.
What changed in the EMA drug–device guideline?
11 paragraphs changed against the 2019 guideline; two change your plans. §4.2 asks for a Notified Body Opinion and comparability data when a variation changes the device part; new §4.3 asks for delivered-dose comparability on three batches when moving from syringe to autoinjector. Both land on the Veltrimab autoinjector variation planned for May 2027 — book the notified body by 30 October.
Which updates this week affect Corventa?
Four, one High. FDA's revised draft guidance asks for 5-year follow-up in pivotal trials, where your PMA supplement plans 3 years. NMPA self-test reports for Class III devices need calibration certificates from 1 March 2027, and NMPA's draft stent guideline accepts overseas data with at least 15% Chinese patients. MHRA registrations of Class IIb and III devices must be renewed every year.
中国的哪些新规定影响我们的产品？
Answered in Chinese, with an English line beneath: two NMPA rules affect Corventa this week — calibration certificates for self-test reports from 1 March 2027, and at least 15% Chinese patients in overseas data under the draft stent guideline.
12 screens from the working solution, on its sample data. Pick one to see it large.
How the edition is laid out, what the agents watch, who confirms and how teams hear are settings — changed rules apply from the next morning's run.
| Setting | Default | Choose from |
|---|---|---|
| Print time | 05:00 CET check · prints about 05:12 | 04:00 · 05:00 · 06:00 CET check |
| Lead story | Highest impact, then nearest deadline | Highest impact, then nearest deadline · Nearest deadline first |
| Agency columns | FDA · EMA · PMDA · NMPA · MHRA | Five columns; every other agency goes under “Also in this edition” |
| Compare revised documents | On | On · Off |
| Who confirms impacts — Biologics | Lena Ortiz | A named approver per product area: Biologics, Small molecules, Devices, Japan, Cross-product and policy |
| Any labeling change for a marketed product | At least High | High · Medium · Low |
| Daily digest send time | 07:00 local time | 06:00 · 07:00 · 08:00 local time |
| Digest language | Team's own language | Team's own language · English for everyone |
Every figure is labelled: a target the solution is built to, an estimate, a typical published result, or a proven one.
“demo” = seen in the working solution, on its sample data · “target” = the design goal, measured in the live solution · “estimated” = our estimate. People, products (Veltrimab, Talmirex, Corventa, Lumora) and the EMA Revision 1 draft and ePI notice, PMDA / MHLW, FDA and NMPA notices in the story are fictional — characters and sample data in the working solution, modelled on real document forms.
Software that watches health authorities for new and changed guidance, regulations and safety communications and tells regulatory affairs what each one means for its products. Regulatory Intelligence adds seven agents that check 64 sources every morning, translate, summarize with citations, compare revised documents with the versions they replace and propose the impact per product, for a regulatory lead to confirm and sign.
The version comparer finds the version the agency names as replaced and compares the two paragraph by paragraph, marking each change as rewritten, new, widened or editorial. It shows the old and new wording word for word, filtered to the changes that affect your plans, and names the team and plan each one lands on.
Yes. Sources include PMDA / MHLW in Japanese, NMPA in Chinese, Swissmedic in German and French, and ANVISA in Portuguese. The translator keeps the original next to every translated paragraph, uses a glossary for regulated terms, and teams can read their digest in their own language.
The impact assessor compares each update with the product portfolio register, the labeling plan and the submission calendar, and proposes High, Medium, Low or Not relevant per product and market, with a reason, the passage behind it and its confidence. Impact rules you set — for example, any labeling change for a marketed product is at least High — set the minimum.
Yes. The agents propose and never confirm. A named lead signs every High and Medium impact, recording name, date, time and meaning, before any team is told, and Low and Not relevant updates are filed automatically with 10% sampled for review each week.
Yes. Watched sources, their schedule, the approver for each product area, impact rules, the print time, the agency columns on the front page and the digest's time and language are all settings. A changed rule applies from the next morning's run.
Yes. The assistant answers in English, Japanese, Chinese or German from the agency updates and your internal plans, and every line links to the exact page — with the original passage and its translation. When nothing answers the question, it says so.
The Agentic Solution Engine builds and deploys it from your requirements and documents — your product portfolio register, labeling plan, submission calendar and the agencies you file with — and it goes live once every quality gate has passed. We will walk you through it on your own portfolio first.
Module 2 summaries drafted in weeks, every statement cited to its source.
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1-min demoWe'll run Regulatory Intelligence on your own products and the agencies you file with.