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The Regulatory Intelligence Workspace
Find answers in seconds. Compare across jurisdictions.
Know what's missing before you submit.
RegAid helps regulatory teams answer questions, compare requirements, and identify gaps across 20M+ official documents from FDA, EMA, Swissmedic, and 10+ other authorities. Every answer cited to the source.
RegAid is built for regulatory affairs managers, regulatory consultants, quality assurance leads, medical device startups, contract research organizations (CROs), and pharma and MedTech compliance teams. Whether you are preparing a 510(k) submission, navigating EU MDR CE marking, comparing ICH guidelines across jurisdictions, or researching Swissmedic requirements, RegAid gives you cited answers from official sources in seconds instead of hours of manual research.
Continue with GoogleWhat stability data is required for a Swissmedic IND submission?
Searched 4 sources
Swissmedic follows ICH Q1A(R2) ich.org for stability data requirements. At the time of IND submission, the following is recommended:
- Long-term data: 12 months minimum at 25°C/60% RH swissmedic.ch
- Accelerated data: 6 months at 40°C/75% RH
- Photostability: per ICH Q1B, required for drug substance and product ich.org
Swissmedic may accept reduced data for early-phase trials, but a commitment to complete the full program must be included in the submission swissmedic.ch.
Jurisdiction
Global
United States (FDA)
European Union (EMA)
Switzerland (Swissmedic)
United Kingdom (MHRA)
Canada (Health Canada)
Nigeria (NAFDAC)
South Africa (SAHPRA)
India (CDSCO)
Japan (PMDA)
Sources
FDA Guidance
EMA Guidelines
Swissmedic Guidance
ICH Guidelines
MHRA Guidance
Health Canada Guidance
eCFR
CRLs
NAFDAC Guidance
SAHPRA Guidance
CDSCO Guidance
PMDA Guidance
Analysis
Analyzing question
Planning retrieval strategy
Searching sources
Reading 12 sources
Drafting grounded answer
Preparing 4 citations
AI Search
Find Answers in Seconds
- One question. RegAid searches, verifies, and cites across 10+ authorities.
- Every answer traceable to the exact section in the source
- Live data from official sources. 510(k) clearances, drug approvals, recalls, and guidance updates in real time.
- Upload your document. See where it falls short.
- Keep the conversation going. RegAid remembers your context.
Precedent Analysis
Compare Requirements Across Jurisdictions
- Tell the AI what to compare. It builds the grid for you.
- Upload your technical docs. See every gap against official requirements.
- Every cell traceable to the source. No guesses.
- FDA vs EMA vs Swissmedic vs Health Canada, side by side
- Export directly into your submissions and reports
Monitoring
Stay Ahead of Every Regulatory Change
- Pick a topic. Choose your sources. Done in seconds.
- New guidance published? You'll know first, with citations.
- Daily or weekly. On your schedule.
- Share with your team. Everyone sees the same updates.
- Every update linked to the source. Click to verify.
Word Add-in
Know If Your Claims Are Supported. Inside Word.
- Select any paragraph and see whether it is supported by official guidance, with a clear verdict and cited evidence
- Find the citation for any claim and insert it inline with one click
- Insert a cross-jurisdiction comparison table directly into your document
- Rewrite regulatory text with tracked changes so reviewers see exactly what changed
- Section-aware review that automatically adapts to the regulatory document you are working on
Every Major Jurisdiction. One Search.
Guidance, approvals, and prescribing info from FDA, EMA, Swissmedic, and 10+ authorities.
| Jurisdiction | Guidance | Approvals | Prescribing Info | Assessments |
|---|---|---|---|---|
| 🇺🇸US (FDA) | US (FDA) Guidance: Covered | US (FDA) Approvals: Covered | US (FDA) Prescribing Info: Covered | US (FDA) Assessments: Covered |
| 🇪🇺EU (EMA) | EU (EMA) Guidance: Covered | EU (EMA) Approvals: Covered | EU (EMA) Prescribing Info: Covered | EU (EMA) Assessments: Covered |
| 🇨🇭Switzerland | Switzerland Guidance: Covered | Switzerland Approvals: Covered | Switzerland Prescribing Info: Covered | Switzerland Assessments: Covered |
| 🇨🇦Canada | Canada Guidance: Covered | Canada Approvals: Covered | Canada Prescribing Info: Covered | Canada Assessments: Covered |
| 🇬🇧UK (MHRA) | UK (MHRA) Guidance: Covered | UK (MHRA) Approvals: Covered | UK (MHRA) Prescribing Info: Covered | UK (MHRA) Assessments: Covered |
| 🌍+ 5 more | + 5 more Guidance: Covered | + 5 more Approvals: Covered | + 5 more Prescribing Info: Covered | + 5 more Assessments: Covered |
| 🌐ICH | ICH Guidance: Covered | ICH Approvals: Not applicable | ICH Prescribing Info: Not applicable | ICH Assessments: Not applicable |
Pricing
Search any regulation. Get cited answers.
Monthly
Full access, billed monthly
CHF 199/ seat / month
20 free searches · 30 days · no credit card
- Unlimited searches with cited answers
- Upload and cross-reference your own documents
- Gap analysis and cross-jurisdictional comparison
- Regulatory change monitoring with cited alerts
- Team workspaces with role-based access
- Shareable sessions and CSV export
- 10+ regulatory authorities covered
Annual
Full access, billed yearly
CHF 1'990/ seat / year
20 free searches · 30 days · no credit card
- Everything in Monthly
- 2 months free (save CHF 398)
- Priority support
Enterprise
For teams that need more
Custom
- Everything in Annual
- Custom source integrations
- Dedicated onboarding
- Priority support
- Volume pricing
Frequently Asked Questions
01
What does RegAid cover?
Pharma and medtech across 10 jurisdictions. Guidance, drug approvals, device clearances, prescribing info, and assessment reports from FDA, EMA, Swissmedic, Health Canada, MHRA, ICH, and more.
02
How is RegAid different from ChatGPT or general AI tools?
RegAid only answers from official regulatory sources. Every answer is cited to the original document. General AI tools have no regulatory source coverage, no citations, no comparison grids, and no change monitoring. If RegAid cannot find a reliable source, it tells you instead of guessing.
03
How accurate are the answers?
Every answer includes clickable citations to the source document. No source, no answer.
04
Does RegAid support CER, PMCF, PSUR, 510(k), and other regulatory workflows?
Yes. Ask workflow questions like "What clinical evidence is required for a Class III CER under MDR?" and get a structured, cited answer. Use comparison grids to map requirements across jurisdictions for any submission type.
05
Can I upload my own documents and compare them against regulations?
Yes. Upload your technical documentation, protocols, or submissions. RegAid compares them against official requirements and shows you exactly where the gaps are, with citations to the source.
06
Can I compare regulations and identify gaps?
Yes. Build comparison grids across any jurisdiction, upload your own documents to identify compliance gaps, and let the AI assistant fill every cell with cited answers.
07
Where is my data stored?
Swiss-hosted (GCP Zurich). GDPR + FADP compliant. Your data is never used to train AI models.
08
How much does RegAid cost?
CHF 1,990/seat/year (or CHF 199/seat/month). Free trial, no credit card required.
09
Can I try it first?
Yes. Sign up and start searching immediately, no credit card required.
10
Can I install RegAid as an app on desktop or mobile?
Yes. RegAid works like a real app on desktop and mobile. You can install it on Chrome or Edge from the address bar, or add it from Safari using Add to Home Screen (iOS) or Add to Dock (macOS).