Compliance & Validation — Documented
SOC 2 Type II, GDPR, 21 CFR Part 11
RegDesk
Regulatory information management platform with AI-assisted intelligence for global medical-product submissions and requirement tracking.
RegDesk, headquartered in Houston, Texas, provides a regulatory information management platform that helps medical device and pharmaceutical companies prepare, submit, and track product registrations across global markets, with AI-assisted alerts when country requirements change. Its trust page documents a third-party SOC 2 Type II certification alongside self-declared GDPR, FDA 21 CFR Part 11, and GxP compliance. Much of the company's public footprint centers on medical devices, so pharma-specific depth should be probed during evaluation.
- Headquarters
- Houston, United States
- Compliance
- SOC 2 Type II, GDPR, 21 CFR Part 11, GxP
- Deployment options
- cloud
- Website
- https://www.regdesk.co
- https://www.linkedin.com/company/regdesk
Categories
AI Use Cases
- Regulatory Submission Authoring
Vendor Scorecard
64% — Partial coverage. Coverage score — how completely Atlas documents RegDesk across 7 buyer-evaluation areas. Reflects available Atlas data, not solution quality.
Deployment & Hosting — Documented
cloud
Pricing Transparency — Not documented by Atlas
Ask the vendor: What is your pricing model, and what drives total cost of ownership?
Implementation & Onboarding — Not documented by Atlas
Ask the vendor: What is a realistic implementation timeline, and what onboarding support is included?
Organization & Role Fit — Documented
Biotech Startup, Mid-Size Biotech, Large Pharma, Regulatory Affairs
Solution Scope — Documented
Regulatory Submission Authoring
Company Viability — Partially documented
Private
Always ask the vendor
Not captured in Atlas data — confirm directly. Excluded from the score above.
Data Rights & IP
Who owns model outputs? Is our proprietary data used to train models others can access, and where does our data reside?
Model Credibility & Explainability
Can you share validation studies or benchmarks, explain how the model reaches its conclusions, and describe how bias and drift are monitored?
Questions to Ask This Vendor
- How deep is coverage for drug submissions in our target markets, versus medical devices?
- How are AI-generated regulatory alerts sourced and verified before they reach us?
- Which compliance claims are third-party audited versus self-assessed?
- What does the submission tracking audit trail look like for inspections?