EXTEDO

Regulatory information management software for submission management, eCTD publishing, and regulatory compliance.

EXTEDO, founded in 1996 and headquartered in Ottobrunn near Munich, Germany, provides regulatory information management software covering submission management, eCTD publishing, product registration, and safety management through its EXTEDOpulse platform. Its tools are used by life sciences companies and by regulatory agencies. EXTEDO is ISO/IEC 27001:2022 and ISO 9001 certified (TÜV SÜD), and has been part of the Bertelsmann Group since February 2024.

Headquarters
Ottobrunn, Germany
Founded
1996
Compliance
ISO 27001
Deployment options
cloud, on-premise
Website
https://www.extedo.com
LinkedIn
https://www.linkedin.com/company/extedo

Categories

AI Use Cases

  • Regulatory Submission Authoring

Vendor Scorecard

64% — Partial coverage. Coverage score — how completely Atlas documents EXTEDO across 7 buyer-evaluation areas. Reflects available Atlas data, not solution quality.

Compliance & Validation — Documented

ISO 27001

Deployment & Hosting — Documented

cloud, on premise

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, CRO / CDMO, Regulatory Affairs, Pharmacovigilance

Solution Scope — Documented

Regulatory Submission Authoring

Company Viability — Partially documented

Private, Founded 1996

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 submission formats and regions (eCTD, regional gateways) are supported out of the box?
  • How does the platform scale from a small biotech to a global RIM deployment?
  • What validation support is provided for regulated document workflows?
  • How is agency-side experience (EMA, national authorities) reflected in the product?