At Certara, behind every successful pharmacometric analysis is a skilled and multidisciplinary team that bridges science, data, and strategy. Experts in clinical pharmacology, biostatistics, and modeling work collaboratively to generate insights that guide decision-making and regulatory communication. Our expertise ensures that population analyses and exposure-response studies are meticulously designed and executed, addressing the complexities of patient variability and therapeutic outcomes. By leveraging the collective knowledge of the team, organizations can facilitate smoother regulatory submission pathways and optimize drug development efforts.
Pharmacometrics for Regulatory Submission Support
Pharmacometrics services for regulatory submissions
建模和模拟服务
Learn more about pharmacometrics for regulatory submission support
The role of an experienced team in pharmacometrics
Tailored submission strategies
Our fit-for-purpose pharmacometrics solutions are designed to address your specific development questions and provide clear support for dose regimens, safety, and efficacy in regulatory submissions.
Streamline regulatory submissions
Certara’s pharmacometrics experts deliver robust analysis to support drug labeling and meet regulatory expectations, ensuring compliance through precise PopPK, PKPD, and exposure-response modeling.
End-to-end regulatory support
With access to clinical pharmacology, regulatory strategy, and additional services, Certara ensures your pharmacometrics analyses are seamlessly integrated into your regulatory package for optimal impact.
Pharmacometrics expertise for regulatory success
我们的服务方案
Pharmacometrics strategy & planning
- Development of strategy and project plans
- Modeling & simulation analysis plans
- Frontloading analyses (early unblinding)
Data analysis & reporting
- PopPK and PKPD modeling
- Exposure-response analysis (efficacy/safety)
- Simulations to support dose regimen justification
- Pharmacometrics reports
Regulatory submission support
- Electronic submission package
- Clinical summaries and labeling components
- Addressing questions during regulatory review
认识我们的专家团队
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专家
Rik de Greef
Senior Vice President, Global Quantitative Sciences Services, Certara Drug Development Solutions
Rik de Greef 是 Certara 公司全球定量科学服务的高级副总裁。Rik 曾在荷兰莱顿大学接受 PK-PD 科学家培训。多年来，Rik 在 Organon 及其后继公司 Schering-Plough 和 Merck/MSD 担任了重要职务。
建立联系
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专家
Amy Cheung, PhD
Vice President, Certara Drug Development Solutions
Dr. Cheung 在阿斯利康制药公司拥有十多年的工作经验，曾担任高级定量药理学家和阿斯利康儿科工作组项目经理。她获曼彻斯特大学博士学位。
建立联系
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专家
Paul Matthias Diderichsen
Senior Vice President, Quantitative Science Services (Europe/Africa)
Paul 精通定量药理学建模、项目领导与客户关系管理，专注于跨治疗领域的决策支持及监管申报工作。
建立联系
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专家
JF Marier, PhD
Sr. Vice President, Integrated Drug Development
JF 在进行 PK、PK/PD 和暴露水平-反应分析以支持各种治疗领域中的给药依据方面，拥有 25 年经验。专长包括肿瘤、罕见病和儿科人群。
建立联系
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专家
Adekemi Taylor, PhD
VP Regional Lead USA, Division 1, Quantitative Science Services
Adekemi 专注于定量药理学策略与分析（涵盖群体药代动力学、PK/PD、疗效与安全性暴露-效应反应及浓度-QTc 模型构建），以支持监管申报、研究设计与整体药物开发。
建立联系
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专家
Mirjam Trame
VP, Certara Drug Development Solutions, Head of Pharmacometrics USA – Division II
Mirjam 是一名药物代谢动力学顾问，在 Certara 公司担任美国药代动力学 II 部门总监。她拥有涵盖多种模式的专业知识，包括复杂生物制剂，并专注于细胞和基因疗法领域。
建立联系联系我们
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
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常见问题解答
什么是定量药理学？
Pharmacometrics involves the modeling and simulation of pharmacokinetics and pharmacodynamics to inform drug development and regulatory decisions.
Certara 如何支持监管申请？
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.
