The journey from preclinical to first-in-human (FIH) studies is both critical and complex. Certara’s nonclinical drug development consulting services are designed to streamline this process with expert support across disciplines such as ADME, toxicology, bioanalytical, and CMC for both small and large molecules. From regulatory strategies to IND-enabling studies, our team ensures a seamless transition into clinical phases. With extensive experience in CRO management, study design, regulatory submissions, and more, we help you mitigate risks and accelerate timelines with confidence.
Nonclinical Drug Development Consulting Services
Expert guidance for
hit-to-lead progression,
first-in-human studies,
and regulatory strategies
in drug development.
Learn more about nonclinical drug development consulting services
Strategic preclinical support for first-in-human preparation and readiness
Integrated regulatory strategy
Comprehensive support from hit-to-lead through regulatory submissions.
Expert-led FIH programs
Tailored solutions designed by a team of seasoned drug developers.
Risk mitigation expertise
Address unexpected safety issues and optimize toxicology programs.
Proven track record
Since 2017, Certara’s Drug Development Solutions team has helped biotech clients generate up to $44 billion in value through IPOs, licenses of drug assets, and acquisitions.
Certara’s nonclinical drug development expertise
Meet our experts
1 / 2
Experts
2 / 2
Experts
Related resources
View allContact us
Partner with Certara for expert nonclinical drug development consulting services. Our team is ready to support your programs from hit-to-lead through FIH studies and regulatory submissions.
Access a team of experienced drug development specialists.
Leverage innovative strategies for accelerated timelines.
Benefit from decades of proven expertise in drug development.
Discover more services
FAQs
What are nonclinical drug development consulting services?
These services include strategic guidance and technical expertise to advance drug candidates from preclinical studies to FIH readiness.
How can Certara support my IND application?
Certara provides comprehensive IND-enabling support, including study design, regulatory submission, and toxicology planning.
What makes Certara different?
Certara combines decades of experience, innovative strategies, and a client-centered approach to deliver results tailored to your program’s needs.
