At Certara, every pharmacometric analysis is powered by a multidisciplinary team of clinical pharmacologists, biostatisticians, and modelers who combine scientific, quantitative, and regulatory expertise. Working collaboratively, they generate robust evidence that withstands regulatory scrutiny. Population analyses and exposure response studies are executed with rigor to characterize variability, justify dose selection, and clearly communicate benefit risk. This integrated approach enables smoother regulatory interactions and more efficient submission pathways, including support for expedited approvals.
Pharmacometrics for Regulatory Submission Support
Regulatory-ready PK and PK/PD analyses built for submission
Accelerate approval with defensible, quantitative evidence for NDAs, BLAs, MAAs, Chinese, Japanese and other regional filings
Learn more about pharmacometrics for regulatory submission support
The role of an experienced team in pharmacometrics
Tailored submission strategies
Tailored pharmacometrics solutions that support dose justification and confirmation of safety and efficacy to strengthen regulatory submissions.
Streamlined regulatory submissions
Flawless execution of regulatory-ready population PK, PK/PD, and exposure–response analyses to speed submissions and reduce questions.
End-to-end regulatory support
Integrated clinical, regulatory, and modeling expertise for high-impact PMx submissions and robust follow-through on any regulatory questions.
Pharmacometrics expertise for regulatory success
Our offerings
Pharmacometrics strategy and planning
- Development of strategy and project plans
- Modeling and simulation analysis plans
- Early frontloading of analyses to reduce program risk
- Expedited pharmacometrics submissions to keep timelines on track
Data analysis and reporting
- Analysis dataset programming
- PopPK and PKPD modeling
- Exposure response analysis for efficacy and safety
- Simulations to support dose regimen justification
- Pharmacometric reports for submissions
Regulatory submission support
- Pharmacometrics guidance for both standard and expedited timelines for NDA, BLA, and MAA submissions
- Electronic submission package
- Clinical summaries and labeling content
- Support in responding to regulatory questions during review
Expedited Pharmacometrics Regulatory Support
Certara’s Expedited Pharmacometrics (PMx) Regulatory Submissions service delivers submission-ready PMx packages in just 4-6 weeks, helping sponsors avoid bottlenecks and cutting traditional timelines by more than half. With global expert resources and standardized, regulator-ready workflows, Certara provides fast, high-quality analyses for NDA, BLA, and MAA submissions.
Supported by 120+ PMx scientists with 800+ regulatory analyses
Front-loaded, parallelized workflows that eliminate common submission delays
Standardized, validated frameworks for rapid, consistent PMx outputs
Complete PMx deliverables: PopPK, exposure-response, simulations, CTD Module 2 & 5
Meet our experts
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Experts
Rik de Greef
Senior Vice President, Global Quantitative Sciences Services, Certara Drug Development Solutions
Rik de Greef is a Senior VicePresident of Global Quantitative Science Services at Certara. Rik was trained as a PK-PD scientist at Leiden University, The Netherlands. Over the years, Rik has taken on roles with increasing responsibilities within Organon and its successor companies Schering-Plough and Merck/MSD.
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Experts
Amy Cheung, PhD
Vice President, Europe/APAC Regional Lead of Quantitative Science, Global Lead of Certara’s Pediatric and Maternal Innovation Engine
Dr. Cheung has more than 20 years of experience in modeling and simulation, as well as clinical pharmacology, with expertise in PBPK/PD mechanistic modelling, special populations (e.g., pediatrics, maternal, and geriatrics), extrapolation, model-based meta-analysis, vaccines, infections, HIV, complex biologics, and different therapeutic areas...
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Experts
Paul Matthias Diderichsen
Senior Vice President, Quantitative Science Services (Europe/Africa)
Paul excels in pharmacometrics modeling, project leadership, and client relations, focusing on decision support and regulatory filings across various therapeutic areas.
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Experts
JF Marier, PhD
Sr. Vice President, Integrated Drug Development
JF has 25 years of experience performing PK, PK/PD and exposure-response analyses to support dosing rationale in various therapeutic areas. Specialties include oncology, rare diseases and pediatric populations.
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Experts
Adekemi Taylor, PhD
VP Regional Lead USA, Division 1, Quantitative Science Services
Adekemi specializes in in pharmacometric strategy and analyses (including population PK, PK/PD, efficacy and safety exposure-response, and concentration-QTc modeling) to support regulatory filings, study design, and general drug development.
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Experts
Mirjam Trame
VP, Certara Drug Development Solutions, Head of Pharmacometrics USA – Division II
Mirjam, a pharmacometrics consultant, serves as the US Lead for Pharmacometrics, Division II, at Certara. With expertise spanning various modalities, including complex biologics, she specializes in Cell and Gene Therapy.
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Our team is ready to assist you with tailored pharmacometrics strategies that optimize drug development and ensure regulatory compliance. Let us help you navigate the complexities of regulatory submissions with confidence.
Proven track record of submission success
Global team with unmatched expertise
Integrated solutions for end-to-end support
FAQs
What is pharmacometrics?
Pharmacometrics involves the modeling and simulation of pharmacokinetics and pharmacodynamics to inform drug development and regulatory decisions.
How does Certara support regulatory submissions?
Certara provides a full spectrum of pharmacometric services, including PopPK, PKPD, and exposure-response analyses, along with expert regulatory guidance.
What sets Certara apart in pharmacometrics?
Our global team, innovative strategies, and integrated approach ensure tailored, impactful solutions for every project.
