Pharma Regulatory Monitoring (v1)
Guidance Changed Overnight. Your Team Already Knows.
ChangeTower watches the FDA, EMA, docket and registry pages your programs depend on and tells you what moved in plain language, with a dated snapshot behind it.
✓ No credit card · First monitor live in 5 minutes
Every page here is under a monitor. ChangeTower checks it on your schedule, stores a dated snapshot, and summarizes what changed in plain language.
The screenshot stored on that check: the page as a visitor saw it, kept with the HTML and never edited.
Detection is content-level: ChangeTower reads the words and the HTML. The screenshot is a dated record of the page, not compared against anything.
Every agency page in one place: guidance, safety, approvals and trials. Open a row to see what changed and how the page looked.
Regulatory guidance now changes faster than any digest can report it.
Regulatory intelligence today waits on a newsletter's cycle and a monthly bookmark sweep. ChangeTower watches the agency pages directly and dates every change.
The monthly sweep
Newsletters, bookmarks and a calendar reminderWith ChangeTower
Pages that check themselvesUS filing, EU dossier, trial landscape. Each in its folder.
Folders mirror how regulatory work is split: by agency, by region, by program. Your monitors grow with the portfolio without turning into a pile.
Sorted the way your team is.
Regulatory, safety and clinical teams watch different pages. Folders group them by who acts, and route alerts to that team.
FDA, EMA and the registries, each in its own folder. Consultancies keep one per client, archives apart.
"When did that deadline move?" is a lookup, not an investigation.
A snapshot is stored on every check, changed or not. The pages your submissions cite become a record, open to any date.
The version history your binder wishes it had.
Citing a guidance means citing what it said on a date. Open that date, read the exact text, export the proof.
From the revised guidance alert to Thursday's submission strategy review.
Explore how ChangeTower improves regulatory intelligence.
Anyone know if FDA has moved on the RWE draft guidance? Need an answer before Thursday's submission strategy review.
Every monitored page captured on the 03:00 check.
AI summary: A revised draft guidance on real-world evidence was posted, replacing the 2024 draft. The comment period closes 12 Sep 2026.
Routed to the channel your team works in. Email, Teams and webhooks carry the same alert.
A revised draft guidance, Real-World Evidence: Considerations for Regulatory Submissions, replaced the 2024 draft. The comment period is open until 12 Sep 2026, and the scope now explicitly covers registry data.
Real-World Evidence: Considerations for Regulatory Submissions (Revised Draft, July 2026). The comment period closes 12 September 2026.
02 Jun 2026: Final guidance: Container Closure Integrity Testing.
18 May 2026: Draft guidance: Comparative Analytical Assessment for Biosimilars.
The screenshot stored on that check: the page as a visitor saw it, kept with its HTML.
Every day in between has a snapshot, changed or not. That is how you answer what the page said on any date.
Every agency move this year, dated and page by page, ready for the strategy review or the board update.
Three links deep in a docket? Monitor it from right there.
Regulatory reading happens in dockets and committee agendas, not a dashboard. The browser extension turns the page you are reading into a monitor.
From open tab to watched source, in one click.
Found the rule that touches your label? Click the icon, say what to watch for, and the docket is monitored.
The proposed rule would revise format and content requirements for prescription drug labeling. Comments are due 06 October 2026.
The agency invites comment on the scope of the proposed requirements and the proposed implementation timeline.
A public docket is open for this rulemaking. Submitted comments are posted to the docket as they are processed.
Effective dates, if finalized, would be announced in the final rule.
Found late on a Tuesday, monitored before the tab closes and archived from its next check.
Plus an in-app activity stream: everything captured and everything changed, in one place.
Built for the signals regulatory teams have to track.
Safety communications, committee opinions, dockets and trial records each move on their own schedule. Set check frequency per page.
Guidance Documents
FDA, EMA and MHRA guidance indexes: new drafts, revisions, final versions, Q&As.
dailyDrug Safety
Safety communications, referral procedures, advisory pages and recall notices.
hourly – dailyApprovals & Authorisations
Novel approvals, CHMP opinions, designation lists, label updates.
dailyRulemaking & Dockets
Federal Register documents, proposed and final rules, comment deadlines.
dailyClinical Trial Registries
ClinicalTrials.gov and EU trial records: status, phases, arms, dates.
daily – weeklyCompetitor Pipelines
Pipeline pages, newsrooms and investor updates across your class.
dailyHealth Authority News
Agency press announcements, enforcement pages, meeting calendars.
dailyReimbursement & HTA
Payer policy pages, formulary updates and HTA body publications.
weeklyYour Own Pages
Your product sites and prescribing information, verified after every update.
daily archiveWhere pharma teams put ChangeTower to work.
Guidance tracking for submission strategy
A revised draft in your therapeutic area surfaces the morning it posts, already summarized. The submission team adjusts the module while the comment window is open.
Safety signals into label impact
Pharmacovigilance watches safety communications, referral procedures and advisory pages across agencies. When new language touches the portfolio, the label impact assessment starts that day.
Trial landscape for launch planning
A competitor study flips to recruiting, adds an arm, or slips its completion date. The launch timing model gets it from the registry page, archived as it looked that day.
An audit trail of awareness
When an auditor or health authority asks when you became aware, the answer is a timestamped snapshot and the alert that followed, exported as a PDF or spreadsheet report.
For regulatory monitoring, turn these on first.
Every plan includes the full toolkit. These are what regulatory teams lean on hardest.
AI Monitoring
Alert rules in your own words: "guidance in our therapeutic areas, not meeting calendars." Every change summarized in plain language.
Explore →Selective Monitoring
Watch just the guidance index or the status field of a trial record. Ignore the rest of the page.
Explore →Content Monitoring
Track the wording that matters: deadlines, dosing language, status lines, at the content and HTML level.
Explore →Scheduled Checks
Set frequency per page: as often as every 5 minutes for safety pages, daily or weekly for the long tail.
Explore →Bulk Setup
Import the full source list in one pass. The SOP's whole page inventory is monitored in an afternoon.
Explore →Slack & Teams Alerts
Push changes into the channel each team already works in, summary attached.
Explore →Built for teams that answer to auditors.
Cloud-based, always on
Nothing to install, nothing to babysit. Checks run on your schedule, at your desk or not.
Encrypted in transit & at rest
Snapshots, credentials and archives are encrypted end to end. Access is granted explicitly, role by role.
A record you can stand behind
Every snapshot is timestamped and immutable, stored exactly as captured. When a health authority asks what the page said in March, show it.
Support that knows the job
Real people help you scope the source list, cadences and alert routing. Included with Enterprise plans.
Questions regulatory teams ask first.
How does pharma regulatory monitoring work?
You name the agency, docket, registry and committee pages your programs depend on, and ChangeTower checks each one on the schedule you set. Every check stores a dated snapshot, and a revised draft or a moved deadline comes back as a plain-language summary of what changed.
What is a snapshot, and how long is it kept?
A dated capture of a page: the rendered page and the HTML behind it, stored on every scheduled check, changed or not. Each carries a precise timestamp and stays retrievable, turning "I think the deadline was different" into a record you can open.
Does this cover EMA, MHRA and other agencies, or just the FDA?
No. FDA is one source of many: EMA, MHRA, TGA and Health Canada pages, Federal Register documents and dockets, clinicaltrials.gov and EU trial records, payer and HTA pages, competitor pipelines and newsrooms. If it's on a page reachable by URL, a monitor can watch it.
We already get a regulatory intelligence newsletter. Where does this fit?
A newsletter tells you what its editors noticed, on its schedule. ChangeTower watches the pages your programs depend on, on yours: every check summarized, every capture archived. Keep the newsletter for breadth; let your monitors carry what can't wait, with the archive answering what a page said on any date.
Will I get too many alerts?
No. That's the point of the AI layer. Describe what matters in plain language: "alert me when guidance in our therapeutic areas changes, ignore meeting calendars and typo fixes". Every change is read and classified before reaching a channel. Minor tweaks are archived without an alert: the record stays complete, the channel quiet.
Can I watch one field or section, rather than the whole page?
Yes. Selective monitoring watches one element or section: a trial record's status line, a comment deadline, one guidance entry. It ignores the rest, so unrelated edits never reach you.
How many agencies, regions or programs can we track?
Yes. Monitor as many domains as your plan covers, in folders: one per agency, program or region. Finding a record later is a filter, not a search, and consultancies keep each client's folders and archives apart.
Can you alert us when guidance or a deadline disappears from a page?
Yes, and often the sharper signal. Name the elements or terms that should be present. ChangeTower alerts you when one goes missing: a guidance quietly withdrawn, safety language removed, a Q&A dropped, a trial arm gone.
What kinds of regulatory pages can ChangeTower monitor?
Any page reachable by URL: guidance indexes, safety pages, dockets, trial registries, committee agendas, agency newsrooms, payer pages, competitor sites. Watch an element, a page or a whole domain, and set check frequency per monitor.
How often are agency pages checked?
You set the frequency per monitor. Daily suits guidance and docket pages, weekly covers the long tail, and a page can be checked more often while a comment window is open.
Where do regulatory alerts get sent?
Email, Slack or Microsoft Teams. Alerts route by folder, so safety communications reach pharmacovigilance and guidance changes reach the submission team.
Can you monitor pages behind a login or a portal?
Yes. Record the steps to reach the page once, including the sign-in and any region or programme picker, and ChangeTower replays them before every check.
Stop learning about guidance changes from the newsletter.
Put the pages your programs depend on under a monitor and build a dated record from today. First monitor live in under 5 minutes.