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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.

Chemistry, Manufacturing, and Controls (CMC) Services
Certara’s expert CMC consultants provide CMC support across all phases of drug development, from early preclinical development to post-market activities.
Transparency & Disclosure
Our tech-enabled clinical disclosure services ensure global regulatory compliance, supporting clear communication and trust in drug development.
Market Access and Pricing
Certara’s Market Access & Commercial solutions provide strategic insights and tools to optimize pricing, reimbursement, and market entry strategies.
Patient Narratives
Expertly written patient narratives, enhanced by CoAuthor, ensuring consistency, quality, and improving safety reporting.
PK/PD Data Programming & Support
Bridge the gap between your analysis plans and modeling requirements.
Medical Affairs and Scientific Communications Services
Our medical affairs consulting services ensure compliance, streamline timelines, and reduce internal burdens.
Document Quality and Management
Certara’s regulatory document quality and management services help sponsors ensure accuracy, compliance, and efficiency in their regulatory submissions.
Drug Interaction Solutions Consulting Services
Certara’s Drug Interaction Consulting Services empower pharmaceutical researchers and regulatory scientists to decode complex drug interactions. By leveraging the scientist-curated
Regulatory Operations
Certara's regulatory operations services optimize processes, ensuring efficiency and compliance throughout the entire submission journey.

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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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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