Advarc
Continuous regulatory pulse
for medical devices and gene therapies.
Advarc scans the FDA, EMA, and Health Canada databases every day, maps each signal to your SKU and dossier, and drafts the corresponding 510(k), pre-sub, IDE, ATMP, CTA, and technical-file updates — so your reviewers ship them after a short sign-off pass.
- Cadence
- 15 min
- Jurisdictions
- 3
- Draft artefacts
- 12+
- FDA510(k) cybersecurity premarket guidance — revisedCDRH · Guidance·→ 510(k) addendumDrafted04:12 ago
- EMALong-term follow-up reporting for gene therapiesCAT · ATMP·→ PSUR §4 updateIn queue27m ago
- Health CanadaLicence amendment window — Class III recallsMDD · Notice·→ Annual licence commitmentDrafted1h ago
- FDAClass I recall — autologous cell therapy lot #A29-114CBER · Recall·→ Field safety noticeTriaged2h ago
- EMANew safety signal — gene therapy Class III adverse eventsPRAC · Signal·→ RWE adverse event summaryIn queue3h ago
- Health CanadaISO 13485:2016 transition closure — Q3 deliverablesHPFB · Guidance·→ Quality manual diffDrafted5h ago
Three regulators, one dossier per SKU.
Every event is tagged with the affected SKU, indication, and CMC section before it lands in your team's queue — so reviewers spend the morning shipping changes, not finding them.
U.S. Food & Drug Administration
CDRH, CBER, CDER, and ORA feeds scraped every 15 minutes.
- New & draft guidance
- 510(k) clearances & summaries
- De Novo grants
- PMA approvals
- Class I–III recall notices
- Warning letters & 483s
- MAUDE adverse-event signals
- 510(k) substantial-equivalence narratives
- Pre-submission Q-sub packages
- IDE & eCTD module updates
- Field safety corrective action notices
European Medicines Agency
CHMP, PRAC, CAT, and MDCG supplements in near-real time.
- CHMP / PRAC opinions
- CAT classifications for ATMPs
- MDCG guidance & Q&A
- EU MDR / IVDR transition deadlines
- Notified Body designations
- PSURs & RMP updates
- Technical file & STED updates
- MAA-specific CMC sections
- PSUR & RMP summaries
- PRAC signal responses
Health Canada · HPFB
MDD, BRDD, NDS, and ANDS streams aligned to MDL cycle timing.
- MDD & BRDD notices
- Medical Device Licence amendments
- NDS / SNDS approvals
- Medical device recalls
- Quality system ISO 13485 guidance
- Risk-class reclassifications
- MDL commitment letters
- Annual Licence Review updates
- Quality manual diff & remediation plan
- Class-specific transition checklists
The gap surfaces weeks before the audit does.
Advarc treats your regulator calendar as a first-class input. Outstanding ISO 13485 evidence, lapsed post-market follow-up, EU MDR / IVDR transition items, and stale Health Canada licence commitments are listed against the next milestone — not after it slips.
ISO 13485 evidence lapses
Design History File for SKU Cardio-RX 4.2 is missing the 2024 management-review record, with three incoming CAPAs still open against 7.3.9.
Lapsed post-market follow-up
Two PMCF surveys for the EU MDR Class IIb wound-dressing line closed without reaching the 80% response target; PMEA needs a refresh before next submission.
EU MDR / IVDR transition items
Six SKUs in your IVDR Annex II list have no declared Common Specifications reference; certificate expiry falls inside your Q2 re-cataloguing milestone.
Stale Health Canada licence commitments
Annual Licence Review for Class III diagnostic RC-22 due in 11 weeks — no PMEA, post-market clinical follow-up, or trend report appended.
From a regulator's notice to a signed draft in under thirty minutes.
The system is built around a four-step loop that's auditable from raw event to shipped artefact. Nothing reaches a Notified Body or auditor without a human signed-off pass.
- 01
Listen
Advarc watches every RSS, mailing list, and database endpoint listed by FDA, EMA, and Health Canada — on a 15-minute cadence, never an overnight batch.
- 02
Classify
Each event is mapped to your SKU list, indication, CMC section, and prior dossier version. Off-target items are filtered against your exclusion set before review.
- 03
Draft
Auto-generated 510(k), pre-sub, IDE, ATMP, CTA, and technical-file drafts cite the sourcing notice, diff against your current dossier, and propose reviewer-ready language.
- 04
Sign off
Reviewer reads the redline, edits in line, and ships — typically under fifteen minutes per item. Nothing reaches a Notified Body until a human has marked it ready.
Gene and cell therapy programs get tailored coverage — not a generic RIM retrofit.
Off-the-shelf regulatory platforms were designed around Class II devices. Advarc's ATMP module keeps separate coverage of long-term follow-up, RMAT and MAA-specific CMC, and real-world adverse-event reporting — the four areas downstream programs report missing on the first Notified Body visit after handover.
- Long-term follow-up obligations
CAT-aligned LTFU protocols for gene-modified cell therapies. Sponsor-specific year 2 → year 15 follow-up matrices and trigger-event maps.
- RMAT & PRIME pathways
Drafted RMAT pre-meeting packages and PRIME eligibility rebuttals tied to the latest CBER and CHMP guidance. Includes KPI tracking for breakthrough designation milestones.
- MAA-specific CMC requirements
ATMP-grade CMC narratives covering starting materials, vector design, lot-release testing, and comparability after process changes — built around the EMA/CAT module structure.
- Real-world adverse-event reporting
Rolling AE summaries across registries, MAUDE, EudraVigilance, and sponsor field data; PSUR-class narratives pre-staged for the next reporting window.
Stop chasing regulatory change. Let it come to you.
Two-minute call with our regulatory-ops lead. NDA available on request. We start with one product, one regulator — and prove the workflow before any rollout.
Join the next cohort
Leave your email and we'll send the next update as soon as your cohort opens — typically 1–2 weeks before public release.