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Toxicology Services for Nonclinical Drug Development

Certara’s Toxicology Services offer tailored, expert nonclinical safety support for successful clinical trials and product registration.

Comprehensive and customized solutions for toxicology solutions

Certara’s Toxicology Services Team is specialized in providing core professional nonclinical drug safety services consulting, to help design and manage programs supporting your product through the regulatory checkpoints. Nonclinical safety services are critical in supporting clinical development in preparation for clinical trials and eventual product registration.

Precision in regulatory strategy

Expert consulting for IND, NDA, MAA, and more, ensuring seamless submission preparation.

Comprehensive program design

Tailored toxicology study planning and execution for all development phases.

Cross-disciplinary collaboration

Integrated teams spanning toxicology, clinical pharmacology and translational medicine, and regulatory affairs.

Due diligence support

Expert preparation of due diligence inspections, including a complete review and gap analysis.

Unparalleled expertise and unique approach

Regulatory submission expertise

Certara has supported 130+ INDs and 30+ NDA/BLA applications, ensuring compliance with regional and global standards.

Experience across the entire drug development process

Offering services from target selection through registration, Certara ensures success at every stage.

Coverage and scientific expertise

Our team of board-certified toxicologists, veterinarians, and developers bring over 125 years of combined experience in small molecules, biologics, cell and gene therapies, antibody therapies, complex biologics, vaccines, and drug-device combinations.

Get to know our toxicology team

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Experts

Marc Bailie, DVM, PhD

25+ years Safety pharmacology, Pharmacology, Pulmonary, Cardiovascular (hypertension, thrombosis, heart failure), Inflammation, Early and late nonclinical program design and execution. Marc is also a thought leader in cardiovascular risk assessment.

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Experts

Steven Duddy, PhD

25+ years Mechanistic toxicology (carcinogenesis), Clinical pathology, Molecular biology, Oncology, Genetic toxicology, Inflammation, Early and late nonclinical program design and execution

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Your partner in drug development

Certara’s Toxicology Services combine unmatched expertise, proven methodologies, and collaborative solutions to help you navigate the complexities of nonclinical drug development. We empower your success through innovative study design, regulatory precision, and cross-disciplinary integration.

125+

Years of combined scientific excellence

Marketed drugs supported in the last 30 years

130

Successful first-in-human packages

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Fact Sheet

Comprehensive and Customized Toxicology Services

Comprehensive overview of toxicology services.

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On-Demand Webinar

AAPS eChalk talk: FDA Modernization Act – What Does it Mean for Pharmaceutical Scientists?

Historically, the FDA has required drug discovery and development programs to include animal testing. With the 2022 passage of the FDA Modernization Act 2.0, the definition of “nonclinical tests” conducted to support pharmaceutical...

Watch now

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On-Demand Webinar

FDA Modernization Act 2.0 – What does it mean for drug developers?

Historically, the FDA has required drug discovery and development programs to include animal testing. This requirement has ended with the 2022 passage of the FDA Modernization Act. This change has...

Watch now

Ready to partner with Certara?

Certara’s toxicology consultants are here to guide you through every stage of drug development, offering trusted expertise and innovative solutions tailored to your needs.

Proven success with 130+ IND submissions.

125+ years of combined scientific excellence

Customized strategies for all drug types.

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