Pharmacometrics for Regulatory Submission Support

Pharmacometrics for Regulatory Submission Support

Optimizing Drug Labeling While Meeting Regulatory Expectations

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Ensure Regulatory Compliance with Pharmacometrics Modeling

Pharmacometrics has become a standard component of regulatory submissions. Population pharmacokinetic (PopPK) analyses are used to characterize the drug’s pharmacokinetics (PK) and the impact of intrinsic and/or extrinsic factors on PK variability. Exposure-response and population pharmacokinetic-pharmacodynamic (PKPD) evaluations of key efficacy and safety endpoints support the justification of the proposed dose regimen for registration.

Global Leaders in Pharmacometrics, with a Proven Record of Success

120+

Pharmacometrics consultants over 5 continents

15+

Dedicated PKPD programmers

250+

Regulatory writers, strategists, and submission experts

Pharmacometrics Services for Regulatory Submissions

We provide a comprehensive spectrum of pharmacometrics services that provide a robust quantitative underpinning to any regulatory submission.

Development of overall pharmacometrics strategy/project plan
Modeling & simulation analysis plans
Potential frontloading of analyses (possibly through early unblinding)
Programming of analysis datasets
PopPK analysis
PKPD modeling

Exposure-response analysis of efficacy or safety
Simulations to support dose regimen justification
Pharmacometrics reports
Electronic submission package
Pharmacometrics components of clinical summaries and labeling
Addressing questions during regulatory review

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Choose Certara: World’s Largest Pharmacometrics Team

With over 120+ pharmacometricians, 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.

Fit-for-Purpose

Our experts are skilled at navigating the complexities of each individual development program by creating fit-for-purpose analysis approaches aimed at addressing the key development questions. At Certara, we overcome our partners’ unique challenges using innovative strategies, and leverage strong science and a deep well of expertise. Our team has numerous years of combined experience working on hundreds of submissions. We are uniquely positioned to deliver pharmacometrics analyses tailored to be informative in supporting key components of the label, while meeting regulatory expectations and program timelines.

Integrated Solutions

As a part of the Certara’s Drug Development Solutions family that includes a wide range of drug development offerings, the team, working closely with Certara Clinical Pharmacology and Regulatory Strategy, is uniquely positioned to help clients put the results of pharmacometrics analyses in the context of their development strategy and achieve optimal impact on decision making. Our expansive regulatory resource base allows us to deliver the full range of summary documents to be included in your regulatory submissions. Furthermore, with access to CMC, DMPK, Toxicology, and Regulatory Services, every project has access to end-to-end support.

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