Pharmacometrics plays a critical role in drug development by integrating knowledge of drug exposure and response to support dose selection, safety, and efficacy. At Certara, we apply advanced PopPK, PKPD, and exposure response modeling to support better, faster clinical decisions, including the full range of pharmacometric analyses required for regulatory submissions, whether on standard or accelerated timelines. As regulatory timelines become more compressed, pharmacometric evidence often sits on the critical path to filing, making timely and regulatory-aligned delivery essential.
Pharmacometrics Services
Optimize drug development and regulatory decisions
Available for both standard and expedited timelines for NDA, BLA, and MAA submissions
Learn more about our pharmacometrics services
Advancing drug development with Certara Pharmacometrics Services
Data-driven decision support
Leverage quantitative frameworks to drive safer, more efficient drug development.
Leverage quantitative frameworks to drive safer, more efficient drug development.
Design smart trials, improving the likelihood of success.
Regulatory-ready analysis
Deliver high quality, compliant PK and PK/PD analyses for submission.
Combining world class pharmacometricians and technology for superior drug development insights
The Certara Pharmacometrics team designs and implements MIDD strategies for all types of drug development programs, regardless of therapeutic area, drug modality, and development phase.
Largest network of global experts
With over 120+ PhD, PharmD, and MD consultants, Certara provides unmatched expertise across therapeutic areas and development phases.
Proven Regulatory Succes
Over 90% of novel drugs approved by the US FDA have used Certara’s software and services.
High-quality datasets
Certara data programmers ensure datasets are ready for fit-for-purpose PK and PK/PD modeling.
Unmatched expertise at every stage of drug development
Certara partnered with KalVista to deliver an FDA-accepted NDA and model-based dosing strategies for HAE.
Meet our pharmacometrics 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
Stephen Duffull
Senior Scientific Advisor, Quantitative Science Services (New Zealand)
Stephen provides advanced pharmacometrics guidance for complex drug development challenges.
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Experts
Matt Zierhut, PhD MBA
Vice President, MBMA Capability Lead, Certara Drug Development Solutions
Matt advances the integration of published clinical outcomes data into development decisions and commercial and regulatory strategy via model-based meta-analysis (MBMA). Matt works closely with clinical development teams to ensure MBMA is leveraged for optimal impact when making the most critical decisions.
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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
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
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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View allPartner with Certara to leverage the world’s most experienced pharmacometrics team. Our experts are dedicated to delivering innovative, regulatory-compliant solutions that optimize drug development outcomes.
Access a team of 120+ pharmacometricians with proven expertise.
Utilize high-quality datasets and advanced quantitative methods.
Maximize success with data-driven decisions at every stage.
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FAQs
What is pharmacometrics?
Pharmacometrics uses mathematical modeling to quantify drug-patient interactions, supporting regulatory decisions and optimizing drug development.
How does Certara support regulatory submissions?
Certara provides regulatory-compliant PK/PD analyses and modeling to ensure successful submission packages.
What phases of drug development does Certara support?
Certara supports all phases, including preclinical, early clinical, and late clinical development.
