Non-Animal Navigator™

The FDA’s plan to phase out animal testing for monoclonal antibodies marks a turning point in drug development. Certara’s Non-Animal Navigator™ empowers you to adapt seamlessly to this new era. Combining 25+ years of expertise with cutting-edge AI-enabled biosimulation, we help you reduce, refine, or replace animal studies while staying aligned with evolving regulatory guidelines.

With thousands of monoclonal antibodies in development, now is the time to future-proof your portfolio. Optimize timelines, cut costs, and generate more predictive, human-relevant evidence with Certara by your side.

Certara delivers tailored solutions to transform your preclinical strategy. With decades of industry-leading experience, we ensure smarter, faster, and more reliable drug development.

Certara is a trusted partner for biopharmaceutical companies and regulatory agencies, with achievements including:

• 80% of PBPK-modeled drugs approved by the FDA leveraging our technologies.
• Regulatory strategies informed by extensive experience with FDA, EMA, and global authorities.
• Tailored programs that combine in silico models, real-world data, and New Approach Methodologies (NAMs) to reduce preclinical timelines.

Certara’s Non-Animal Navigator™ positions you to lead in the next generation of drug development. By combining scientific rigor, innovative models, and regulatory alignment, we help you achieve faster, safer, and more ethical results.