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.
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.
Learn more about Cell and Gene Therapy services
Pioneering solutions for cell and gene therapy development
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.
Certara’s expertise in cell and gene therapy
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.
Meet our experts
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Experts
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Oxana Iliach, PhD
Senior Director, Regulatory Strategy
Specialist in regulatory pathways for rare diseases and biosimilars.
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Experts
Piet van der Graaf, PharmD, PhD
Senior Vice President, Quantitative Systems Pharmacology
An industry leader with over 200 published articles on drug development.
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Maximilian Vargas, PhD, MBA
Vice President, US Access Strategy
Expert in evidence-based value and access strategies.
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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.
