New Approach Methodologies (NAMs)
Redefining drug development
NAMs are important - why?
The global drug development landscape is evolving rapidly. Regulatory agencies including European Medicines Agency (EMA), Food and Drug Agency (FDA) , and other global regulators such as DEFRA are accelerating adoption of NAMs in the early non-clinical phase of drug development. These shifts are creating new opportunities for scientists to de-risk programs earlier and more effectively.
The experienced scientific teams at Concept Life Sciences are helping to lead the way and can help you navigate this evolving regulatory environment with confidence.
What are new approach methodologies?
NAMs are innovative in vitro testing strategies that integrate advanced biological models, computational tools and translational science to assess safety, efficacy, and mechanism of action (MoA).
With integrated discovery and development expertise our multidisciplinary teams work collaboratively to ensure your NAMs strategy is scientifically robust, operationally efficient, and aligned with regulatory expectations.
Delivering an integrated NAMs strategy, with end-to-end NAMs solutions, the key components are:
These approaches improve early decision-making and reduce late-stage development risk.
Supporting your NAMs strategy
We partner with you at every stage of development to deliver tailored NAMs solutions:
Strategic assessment of program needs
Discuss your development strategy
Selection of optimal NAMs platforms
Custom study design
Integrated data analysis
Receive regulatory guidance
Regulatory-aligned reporting
Ongoing scientific consultancy
Our approach ensures your NAMs investment delivers measurable scientific and commercial value. Transform your non-clinical strategy with a partner trusted by innovators worldwide.
Complete the form below to speak with a NAMs expert and receive a personalized consultation with our scientific team about your program.
