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Cell and Gene Therapy Services

End-to-end support

De-risk and accelerate your drug development journey with our expertise from R&D to market access.

Pioneering solutions for cell and gene therapy development

Cell and gene therapy services offer transformative solutions to treat, prevent, or potentially cure diseases at their genetic roots. However, the path from discovery to commercialization is fraught with complexity, including safety concerns, regulatory uncertainty, and pricing challenges. Certara’s integrated approach combines cutting-edge modeling and simulation, regulatory expertise, and market access strategies to guide you through these obstacles. Our solutions de-risk and accelerate your drug development journey, ensuring your therapies reach patients effectively and efficiently.

Expertise across drug development

Our team brings decades of experience across pharmacometrics, mechanistic modeling, and regulatory science.

Advanced Virtual Twin-QSP modeling

Our proprietary platform predicts optimal dosing regimens, reducing risks in clinical trials.

Streamlined market access

Navigate pricing and reimbursement challenges with Certara’s Evidence and Access solutions.

Regulatory excellence

Prepare for successful submissions with our proven regulatory strategies.

Our offerings

Early development services

Streamline preclinical and clinical phases.

Regulatory affairs consulting

Achieve seamless regulatory approvals.

Quantitative systems pharmacology

Optimize dosing with advanced modeling.

Market access & pricing solutions

Ensure successful therapy adoption.

Why us

Certara’s Cell and Gene Therapy services combine deep scientific expertise, innovative technologies, and a commitment to quality. Our integrated approach supports every phase of drug development, helping you mitigate risks, make informed decisions, and accelerate your program’s success. Partner with us to transform your challenges into opportunities.

Contact us

Contact us

Certara is your trusted partner in advancing cell and gene therapy programs. With unmatched expertise in drug development, innovative modeling technologies, and a proven track record of success, we help you navigate the complexities of this emerging field. Let’s work together to bring life-changing therapies to patients.

Expertise in over two dozen cell and gene therapy programs.
Proprietary Virtual Twin-QSP platform for optimized dosing.
Proven strategies for regulatory and market success.

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FAQs

What makes Certara’s Cell and Gene Therapy services unique?

Certara combines modeling and simulation with regulatory and market expertise to ensure success across all stages of development.

How does the Virtual Twin-QSP platform work?

It simulates patient-specific attributes to predict optimal dosing regimens, reducing risks in clinical trials.

Can Certara help with regulatory submissions?

Yes, our team specializes in managing complex regulatory submissions for cell and gene therapies.