At Certara, we consult with you to address all your drug development challenges. We can streamline every stage of development by providing a tailored solution that combines model informed drug development with expertise across due diligence, CMC, toxicology, DMPK, regulatory strategy, clinical pharmacology, modeling & simulation, biometrics, and more. By uniting data, insights, and expert-driven strategies, we help you deliver new therapies to patients faster, with the precision and confidence that you seek.
Drug Development Services
Enhance and optimize your drug development process with decades of experience
Let’s get together to make your drug better
300
FDA and global regulatory submissions supported
90
Certara’s customers have received 90% or more of all novel drug approvals by the FDA from 2014 through 2024.
700
drug development scientists and experts to advance your program leveraging tech-enabled decision-making
Our Early Phase Clinical Development solutions provide expert support at every stage, from Candidate Selection through Phase 1.
Analysis and strategies with the main objective of ensuring a successful drug development program.
Strategic guidance and end-to-end support to navigate global regulatory pathways, ensuring efficient and compliant drug development from preclinical stages through
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.
Expert nonclinical drug development consulting services, from hit to lead identification, into first-in-human studies and regulatory strategy.
Accelerate success with our expert drug development strategy consulting, project management, clinical oversight & operational support services.
Our drug development project management services streamline complex workflows, ensuring your projects are delivered on time & within scope.
Integrated solutions for drug development
Advance your drug’s development journey with a seamless, model-informed approach. By linking insights across all phases, we tailor MIDD-driven strategies to optimize execution and empower confident decision-making—helping you bring innovative therapies to patients faster.
Drug development case studies
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We know that we can transform any part of your drug development journey with Certara’s expertise.
Proven expertise across drug development phases.
Trusted by leading regulatory agencies worldwide.
Unmatched integration of insights, data, and technology.
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