Compliance & Validation — Not documented by Atlas
Ask the vendor: Which compliance certifications (HIPAA, 21 CFR Part 11, SOC 2, GxP) do you hold?
Celegence
Regulatory affairs services and software company whose CAPTIS platform applies AI to submission authoring and management.
Celegence, headquartered in Downers Grove, Illinois, combines regulatory affairs consulting with its CAPTIS platform, which applies generative AI to regulatory document authoring, literature review, and submission management for pharmaceutical and medical device companies. Vendor-reported efficiency figures from client engagements are marketing claims and should be validated in a scoped pilot on your own document types.
- Headquarters
- Downers Grove, United States
- Deployment options
- cloud
- Website
- https://www.celegence.com
- https://www.linkedin.com/company/celegence
Categories
AI Use Cases
- Regulatory Submission Authoring
Vendor Scorecard
50% — Partial coverage. Coverage score — how completely Atlas documents Celegence 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
Natural Language Processing, 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
- Which document types does CAPTIS support for AI-assisted authoring today?
- How is generative output reviewed and locked before submission use?
- What is the split between software subscription and consulting services?
- Can efficiency claims be validated in a pilot on our own documents?