Compliance & Validation — Documented
GxP validated, 21 CFR Part 11, SOC 2 Type II, ISO 27001
Certara
Biosimulation and regulatory science platform accelerating drug development and market access.
Certara provides biosimulation software and technology-enabled services to optimize drug development and regulatory decision-making. Their platform integrates PBPK modeling, population PK/PD analysis, clinical pharmacology, and regulatory intelligence to help companies design better trials, support submissions, and achieve faster approvals.
- Headquarters
- Radnor, United States
- Founded
- 1999
- Compliance
- GxP, 21 CFR Part 11, SOC 2 Type II, ISO 27001
- Deployment options
- cloud, on-premise, private-cloud
- Website
- https://www.certara.com
- https://www.linkedin.com/company/829701
Categories
AI Use Cases
- Protocol Design Optimization
- Regulatory Submission Authoring
Vendor Scorecard
100% — Complete coverage. Coverage score — how completely Atlas documents Certara across 7 buyer-evaluation areas. Reflects available Atlas data, not solution quality.
Deployment & Hosting — Documented
cloud, on premise, private cloud
Pricing Transparency — Documented
Module based license
Implementation & Onboarding — Documented
3–6 months
Organization & Role Fit — Documented
Biotech Startup, Mid-Size Biotech, Large Pharma, Top 20 Pharma, CRO / CDMO, Regulatory Affairs, R&D Leadership, Data Management, Clinical Operations
Solution Scope — Documented
Regulatory Submission Authoring, Trial Protocol Optimization
Company Viability — Documented
Public, $0 raised, 1900+ employees, Founded 1999
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?
Clinical Trial Activity
1 registered trial where Certara is the lead sponsor. Source: ClinicalTrials.gov, verified 2026-07-29.
Top conditions studied: Covid19, SARS-CoV Infection
- International Registry of Healthcare Workers Exposed to COVID-19 Patients (UNITY Global) (NCT04626076, completed)
Evidence & Outcomes
FDA renewed and expanded its Simcyp biosimulation licensing agreement
The U.S. FDA renewed and expanded its long-standing collaboration licensing Certara's Simcyp physiologically-based pharmacokinetic (PBPK) simulator, with hundreds of agency licenses used to inform regulatory review of drug dosing and interactions.
press release (Certara (GlobeNewswire)) · 2021-12-21 — Partner: U.S. FDA
Questions to Ask This Vendor
- Which regulatory agencies accept Simcyp PBPK for biowaivers?
- How does Pinnacle 21 integrate with our existing submission workflow?
- What qualified person support is included for GxP validation?