Sofie Regulatory Intelligence
NewThe entire regulatory world.One question away.
Official regulations, guidance, inspections, recalls, shortages and approvals from nine authorities, refreshed every day. Search it, compare it, trend it and build on it, with every answer traced to its source.
- structured records
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- official documents
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- live source connectors
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- authorities
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structured records
official documents
live source connectors
authorities
Manyteamscananswerwhataguidancesays.Fewercanquicklyanswerwhatishappeningacrossmarketsthatcouldaffectthisproduct,thisfacilityorthisprogram.ThatisthequestionRegulatoryIntelligencewasbuiltfor.
Ask
Every claim, cited.
Ask which CDMO has the cleanest inspection history, what changed in aseptic guidance, or who else makes your API. Sofie works through inspection outcomes, 483s, certificates and labels, then answers with the official record behind every sentence.
- Official source, with page or section and an archived copy
- Draft and withdrawn material excluded unless requested
- Gaps named, never filled from memory
Researching across 9 authorities
Sources · official records
Inspection classification · Basel · NAI
fda.gov/inspections-compliance…
EudraGMDP certificate · Keller Pharma AG
eudragmdp.ema.europa.eu
Form 483 · Alameda, CA · Jun 2026
fda.gov/…/foia-electronic-reading-room
Guidance · Sterile drug products, aseptic processing
fda.gov/regulatory-information/…
SPL · establishment listing · Keller
dailymed.nlm.nih.gov
What teams do with it
Beyond search. Operate with market-wide visibility.
01
Research current requirements
Ask in plain language. Sofie reads the regulation, guidance or record and answers with the official source, its status and dates, and the page or section.
02
Compare across regulators
Line up FDA, EMA, Health Canada, PMDA and others side by side, with evidence from each named authority.
03
Count and trend records
Recalls, shortages, approvals, inspection outcomes and safety actions, counted and trended by product, company, facility or market.
04
Profile a company or site
Everything regulators have published about a drug, sponsor or facility across markets, matched by name and identifiers such as FEI, NDA and ANDA.
05
Read long documents systematically
Work through a regulation page by page, section by section or by outline, instead of hoping a search found the right passage.
06
See what changed since a date
Every refresh records what was added, revised, withdrawn or removed, and keeps before-and-after copies. Revisions get an automatic materiality check.
Coverage
Nine authorities. 36 live sources.
Regulations, guidance, publications and regulator data, drawn only from official domains and checked every day.
U.S. FDA
21 CFR, guidance, Federal Register, warning letters, Form 483s and EIRs, inspection classifications and citations, recalls, shortages, Drugs@FDA, establishment registrations, DailyMed, ClinicalTrials.gov
14 sources
Health Canada
Guidance, Drug Product Database, Notices of Compliance, recalls, inspection outcomes, summary decisions
6 sources
EU / EMA
EudraLex Volume 4, EMA publications, safety and shortages, EudraGMDP certificates and non-compliance statements
5 sources
PMDA / MHLW
Guidance, drug approvals and review reports, drug safety
3 sources
TGA
Guidance, medicine shortages, market actions and alerts
3 sources
WHO
Pharmaceutical guidelines and Technical Report Series
2 sources
ICH
The full guideline index, Q, S, E and M series
1 source
PIC/S
GMP guides and publications
1 source
USP
Revision notices: PF proposals, Revision Bulletins, IRAs (metadata only)
1 source
FDA drug establishment registrations
10,477 sites. 83 countries.
Every FDA-registered drug site, linked to more than 150,000 drug labels, ready to profile by company, product or country.
10,477 FDA-registered drug sites · 83 countries
Inspection readiness
Know what FDA actually cites.
Every citation FDA has published for drug inspections since FY2022, counted by 21 CFR section. Check the most-cited requirements against your last mock audit, then open the CAPA drafts for review.
Most-cited 21 CFR 211 sections
FDA drug inspections · FY2022–26
- §211.22(d)Covered
Quality unit procedures not written or followed
737 - §211.192Gap
Discrepancy and failure investigations
725 - §211.100(a)Covered
Absence of written procedures
501 - §211.160(b)Covered
Scientifically sound laboratory controls
409 - §211.68(b)Gap
Backup data not exact and complete
336 - §211.113(b)Covered
Procedures for sterile drug products
321 - §211.67(a)Covered
Cleaning, sanitizing, maintenance
281 - §211.84(d)(2)Covered
Component identification test
259
Sofie
Two gaps against what FDA cites most: investigations (§211.192) and backup data (§211.68(b)). CAPA drafts are ready for review.
What changed
Since Sep 23 · 9 authoritiesSterile Drug Products Produced by Aseptic Processing
Section IX.B · Environmental monitoring · illustrative excerpt
Monitoring should be performed during each production shift at locations the firm considers appropriate. Results should be trended and reviewed by the quality unit.
Monitoring
Tracked every day. What changed.
Each refresh records material that was added, revised, withdrawn or removed, with before-and-after copies. Revisions to guidance, regulations and enforcement records get an automatic materiality check, so substantive changes stand apart from housekeeping.
- 6 h
- recalls, shortages, market actions
- Daily
- every other source, with quality gates
- Weekly
- EU GMP certificates
Build on it
Now build on it.
Regulatory Intelligence is part of Sofie, so the evidence flows straight into the rest of your work.
Suppliers tracked
40
Need review
2
Open SCARs
7
Next audit
Nov 14
A supplier-risk command center
A live Surface that tracks your approved suppliers' inspections, 483s and certificates, and updates as regulators publish.
Run · task breakdown
Change impact review
Build an orchestration that gathers the week's relevant changes, assesses their impact and drafts notices for your approval.
Your sequences
Supplier 483 alerts
Regulatory change published
Weekday quality brief
Every weekday 7:00
Meeting follow-ups
Transcript ready
USP revision alerts
Regulatory change published
When
FDA posts a Form 483 for a supplier on your list
Approved suppliers · 57 sites
Then
Run Supplier Risk orchestration
Updates the Supplier risk Surface
Then
Notice to Quality, drafted by the run
Needs approval before sending
Notify if
Observations mention sterility or aseptic processing
Checked after each run
Run log · today
Checked dailyRegulatory alerts
Sequences that alert you when FDA posts a 483, warning letter or OAI for one of your suppliers, or when USP lists a revision.
“What used to take me half a day searching through guidances and cross-referencing documents, Sofie handled in seconds. The answer was there; the references were there; nothing left to chase down.”
Questions
Designed for traceable review
Where does the content come from?
Only official regulator and standards-body sources: 36 live connectors across nine authorities. Every result links to the official source, with the page or section for documents and an archived copy when the original moves.
How current is it?
Recall, shortage and market-action feeds are checked every six hours. Every other source is checked at least once a day, busy ones more often, and EU GMP certificates update weekly. Sofie reports when a feed is behind.
What happens when the evidence isn't there?
Sofie says so. It names the gap rather than filling it from model memory, and excludes draft and withdrawn material unless you ask for it.
Are there coverage limits?
Yes, and we publish them. Health Canada guidance coverage is still limited, TGA's full product register isn't included because TGA offers no machine-readable export, and USP is covered as revision metadata only because USP–NF text is licensed.
Is this legal or regulatory advice?
No. Sofie summarizes the available evidence and shows its sources so your experts can make the determination.
See Regulatory Intelligence
on your products.
Bring a product, a supplier list or a guidance you're tracking. We'll show you what Sofie finds, with every source attached. Regulatory Intelligence is available now in beta.