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Transformative services for drug development

Transform the pace and quality of drug development using services that build on decades of experience.

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Level up your drug with our services

At Certara, we offer a comprehensive suite of services designed to progress your drug or therapy to the next stage of maturity. Our expertise spans across all domains of drug development to give you comprehensive insights, clarity and direction to reach success.

Driven by extensive expertise in drug development, regulatory affairs, market access, and commercialization, coupled with deep scientific knowledge on a global scale.

Streamline development and drug development support with tailored MIDD-driven strategies across all phases to optimize execution and decision-making.

Reach the right audience at the right time with expert planning and writing support. Our services meet regulators’ expectations and support your submissions in any phase.

Early Development
Our Early Phase Clinical Development solutions provide expert support at every stage, from Candidate Selection through Phase 1.
Regulatory Affairs Consulting
Strategic guidance and end-to-end support to navigate global regulatory pathways, ensuring efficient and compliant drug development from preclinical stages through
Pharmacometrics Services
Our experienced pharmacometrics services team helps quantify drug-patient interactions, optimize development & regulatory choices.
Quantitative Systems Pharmacology
Choose Certara's Quantitative Systems Pharmacology (QSP) consulting services to enhance drug development with computational modeling and experimental data.
Clinical Pharmacology
Analysis and strategies with the main objective of ensuring a successful drug development program.
Simcyp PBPK
Global consulting team applying PBPK modeling to all stages in drug development.
Biostatistics and Statistical Programming
Advanced biostatistics consulting and CDISC-compliant SDTM & ADaM datasets
Regulatory Writing
Our regulatory writing services offer expertly crafted, high-quality documents for drug development, ensuring compliance and timely submissions.
Real World Data Solutions
Discover Certara's comprehensive Real-World Evidence Services. We provide innovative RWE solutions for pharma, empowering regulatory, market access, and clinical strategies.

Seamless support across every stage of drug development

Certara’s integrated services empower you to tackle challenges at every stage of drug development. By uniting expertise across discovery, preclinical, clinical, commercial and market access, and regulatory phases, our vision is that information flows freely, providing you with actionable insights that enhance safety, efficiency, and success.

This holistic approach means that every decision you make is better informed, every development phase supports the next, and your drug achieves new heights. With Certara, you gain predictive, evidence-based strategies, reduced effort, and greater confidence in bringing life changing therapies to patients faster.

Therapeutic specialties

Oncology

Accelerate oncology drug development with expertise that spans preclinical models to regulatory strategies, delivering precise solutions for complex cancer therapies.

Rare disease and orphan drug

Overcome the unique challenges of rare disease development with tailored solutions that de-risk processes and ensure regulatory and market success.

Complex biologics

Navigate the complexities of oligonucleotide biologics with advanced modeling and tailored strategies, enhancing development and regulatory outcomes.

Pediatrics

Address pediatric development challenges with expert guidance, ensuring therapies meet stringent safety and efficacy standards for children.

Cell and gene therapy

De-risk and streamline cell and gene therapy development with integrated solutions that accelerate progress from discovery to patient access.

Model-informed vaccine development

Optimize vaccine development with model-based strategies, predicting efficacy and safety to accelerate timelines and improve public health impact.

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We know – we have a formidable and comprehensive range of services to help you progress your drug or therapy to the next stage of maturity. Do send an inquiry and we’ll connect you to the expert that can serve you best.

Certara’s customers have received 90% or more of all novel drug approvals by the FDA from 2014 through 2024.
Seamlessly integrate the right expert at any development stage.
Reduce timelines, costs, and risks with our proven, trusted solutions.

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If you need Technical Support please visit our support portal.
If you're interested in applying for a position at Certara please visit careers.certara.com for more information.

Discover more about Certara

Solutions

Explore how Certara’s integrated services drive success across every stage of drug development. From discovery to regulatory submissions, we deliver evidence-based, faster, and more efficient solutions tailored to your challenges.

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Software

Unleash the power of Certara’s industry-leading software. Predict outcomes, optimize processes, and ensure data-driven decisions with tools trusted by global regulators and researchers alike.

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About us

Learn more about Certara’s mission to transform drug development for good. With decades of expertise and proven success, we’re your trusted partner in innovation and progress.

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