Certara Cuts Pharmacometrics Submission Timelines in Half: New Expedited Service Accelerates Global Regulatory Filings

Radnor, PA — 2025 年 12 月 1 日 — Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, today announced the launch of its Expedited Pharmacometrics (PMx) Regulatory Submissions offering, enabling sponsors to deliver complete PMx submission packages in four to six weeks – reducing typical timelines by more than half.

Pharmacometrics analyses, which apply modeling to non-clinical and clinical data to predict PK/PD, understand disease progression, and optimize trial design, are essential to regulatory decision-making supporting dose justification, evaluating efficacy and safety across populations, and reinforcing the overall benefit–risk assessment. Because many PMx activities must be performed sequentially, they frequently become a bottleneck for new drug (NDA), biologics license (BLA), and marketing authorization (MAA) applications.

To help sponsors mitigate timeline risk and meet accelerated development goals, Certara has established a streamlined, proven pathway that has included support for over 800 high-quality, submission-ready PMx analyses for global regulatory agencies including FDA, EMA, PMDA, and MHRA in the past four years. The offering leverages the industry’s largest and most experienced PMx submissions team of over 120 scientists, combining scientific rigor with operational efficiency.

“Biopharmaceutical companies are under pressure to meet rapid regulatory timelines without compromising analytical quality,” said Adrian McKemey, President, Drug Development Solutions. “With the expedited option, sponsors can be confident that pharmacometrics deliverables will not delay their filings, even in compressed or late-stage development scenarios.”

A four- to six-week submission-ready PMx package may include:

• Population PK and exposure–response analyses
• Comprehensive simulations using Phase 1–3 clinical trial data to support dose regimen justification
• Full pharmacometrics analysis reports
• CTD Module 2 and 5 components formatted for direct inclusion in the eCTD

The accelerated model applies multiple timeline-optimizing strategies, including detailed project planning, front-loading of key activities, use of scaled global expert resources for 24-hour productivity, standardized scripts and templates, and well-orchestrated, proactive communication among stakeholders to ensure timely decision-making.

“This capability underscores our commitment to delivering efficient, predictable regulatory submissions,” said Rik de Greef, SVP, Quantitative Science Services. “Whether for traditional filings, rolling submissions, or accelerated approvals, Certara provides scalable expertise to keep programs on track.”

Availability

The Expedited Pharmacometrics Regulatory Submissions offering is available globally. To learn more, visit this page.