While New Approach Methodologies hold promises to reduce animal use in drug development, regulatory concerns still persist. These include questions about global regulatory acceptance, the translatability of NAMs for human risk assessment, and the short-term impact on cost and timelines until broader validation is achieved.
Certara’s regulatory and drug development experts partner with companies to assess, design, and implement best-fit NAM strategies tailored to their specific development programs. Our approach combines deep regulatory insight, scientific rigor, and cross-functional expertise to deliver strategies that accelerate development while supporting global regulatory alignment.
