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.
Transformative services for drug development
Transform the pace and quality of drug development using services that build on decades of experience.
Contact us
Level up your drug with our services
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.
Our Early Phase Clinical Development solutions provide expert support at every stage, from Candidate Selection through Phase 1.
Discover expert insights on biotech funding, startup investment strategies, and securing capital for biotech ventures. Empower your growth with proven
Partner with Certara for data-driven due diligence, asset evaluation, and risk mitigation to support smarter biotech investments and portfolio growth.
Strategic guidance and end-to-end support to navigate global regulatory pathways, ensuring efficient and compliant drug development from preclinical stages through
Our experienced pharmacometrics services team helps quantify drug-patient interactions, optimize development & regulatory choices.
Choose Certara's Quantitative Systems Pharmacology (QSP) consulting services to enhance drug development with computational modeling and experimental data.
Analysis and strategies with the main objective of ensuring a successful drug development program.
Global consulting team applying PBPK modeling to all stages in drug development.
Advanced biostatistics consulting and CDISC-compliant SDTM & ADaM datasets
Our regulatory writing services offer expertly crafted, high-quality documents for drug development, ensuring compliance and timely submissions.
Discover Certara's comprehensive Real-World Evidence Services. We provide innovative RWE solutions for pharma, empowering regulatory, market access, and clinical strategies.
Leverage Certara’s expertise in model-based meta-analysis to enhance trial design and decision-making.
Expert nonclinical drug development consulting services, from hit to lead identification, into first-in-human studies and regulatory strategy.
Our Toxicology Consultants provide core professional nonclinical safety services consulting, to help support your product through regulatory stages.
Certara’s expert CMC consultants provide CMC support across all phases of drug development, from early preclinical development to post-market activities.
Our nonclinical & clinical DMPK & ADME Consulting Services support a wide range of offerings to advance early drug development.
Our tech-enabled clinical disclosure services ensure global regulatory compliance, supporting clear communication and trust in drug development.
Pharmacovigilance (PV) writing services for seamless drug safety and pharmacovigilance document compliance, leveraging advanced expertise and technology.
Certara’s Market Access & Commercial solutions provide strategic insights and tools to optimize pricing, reimbursement, and market entry strategies.
Certara’s Complex Biologics Services provide advanced support for CAR-T, monoclonal antibodies gene therapies. Trust our expertise to navigate regulatory pathways
Partner with Certara for Clinical Pharmacology Regulatory Strategy to optimize drug development pathways and navigate complex regulatory landscapes.
Expertly written patient narratives, enhanced by CoAuthor, ensuring consistency, quality, and improving safety reporting.
Certara's Pediatric MIDD Accelerator advances efficient and reliable pediatric drug development processes that optimize dosing and get critical medicines to
Bridge the gap between your analysis plans and modeling requirements.
Certara’s Regulatory Submissions Services: Expert guidance for IND, NDA, BLA, and MAA submissions, ensuring quality, efficiency, and compliance for biopharmaceutical
Our medical affairs consulting services ensure compliance, streamline timelines, and reduce internal burdens.
Accelerate success with our expert drug development strategy consulting, project management, clinical oversight & operational support services.
Certara’s regulatory document quality and management services help sponsors ensure accuracy, compliance, and efficiency in their regulatory submissions.
Certara’s Drug Interaction Consulting Services empower pharmaceutical researchers and regulatory scientists to decode complex drug interactions. By leveraging the scientist-curated
Our drug development project management services streamline complex workflows, ensuring your projects are delivered on time & within scope.
Certara's regulatory operations services optimize processes, ensuring efficiency and compliance throughout the entire submission journey.
Certara Global Health (CGH) brings together talent, technology, and software to accelerate the development of medicines for those that need
With 25+ years of HEOR consulting expertise, we offer HTA health economic analyses, clinical trial analytics for HTA applications, epidemiology
Explore our payer engagement strategies. Access expertise in HTA, clinical assessments & decision-making processes to optimize market access.
Certara’s US Managed Markets solutions support scientific value story development, payer engagement and multi-faceted go-to-market strategies.
Explore Certara's Value and Access services, a combination of proven payer strategies and scientific excellence to optimize market access.
Early HTA engagement helps ensure timely reimbursement and optimized market access strategies by aligning clinical evidence with HTA requirements.
Virtual Bioequivalence (VBE) is when bioequivalence of generic is demonstrated using modeling and simulation in lieu of clinical studies
By leveraging quantitative models, regulatory expertise, and real-world data, we empower our partners to fast-track innovative therapies while meeting stringent
Streamline first-in-human studies with physiologically based modeling to optimize dosing and reduce trial risks.
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.
Related resources
View allContact us
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 2025.
Seamlessly integrate the right expert at any development stage.
Reduce timelines, costs, and risks with our proven, trusted solutions.
Send an Inquiry
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.
Learn more
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.
Learn more
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.
Learn more
