New Approach Methodologies

The successful use of NAMs depends on regulatory context and scientific interpretation. Our experts apply NAMs as part of a structured, endpoint-driven strategy, ensuring that alternative methods are used only where appropriate, justified, and regulatorily defensible.

What is it?

New Approach Methodologies (NAMs) are modern scientific approaches used to assess the safety of chemicals and products without relying solely on traditional animal testing. They combine advanced laboratory methods, computer-based models, and existing scientific knowledge to deliver robust, regulatorily accepted safety data.

Rather than relying on a single test, NAMs integrate different sources of data to build a scientifically robust safety assessment.

Regulatory frameworks such as REACH, Biocides, and Cosmetics increasingly encourage the use of NAMs where scientifically justified, helping companies meet compliance requirements more efficiently, ethically, and cost-effectively.

What you get

Client-focused delivery

Expert consultants

Address specific regulatory data requirements

Are aligned with current guidance and acceptance criteria

Support clear hazard, exposure, and risk conclusions

What we offer

We support clients across the full regulatory submission process, ensuring NAMs are applied, documented, and presented in a regulatorily acceptable way.

Strategic NAM Assessment & Testing Design

We offer data gap analysis and identification of opportunities for NAM-based adaptations, as well as the design of NAM-driven testing strategies, aligned with regulatory frameworks.

Read-Across, Grouping & Computational Toxicology

We offer read-across and substance grouping justifications, alongside in silico assessments, including QSAR and computational toxicology.

In Vitro & Integrated Evidence Assessment

We offer in vitro study design, commissioning, and oversight, where required, together with Weight-of-Evidence assessments integrating multiple data sources.

Regulatory Documentation & Dossier Integration

We offer regulatory documentation and dossier integration (e.g. IUCLID).

Our Process

Stage 1: Understanding Your Needs

We start by understanding your substance, product, and regulatory goals.

Stage 2: Strategy Design

We then design a tailored NAMs strategy that balances scientific robustness, regulatory acceptance, cost, and timelines.

Stage 3: Regulatory Submission Support

We support clients across the full regulatory submission process, ensuring NAMs are applied, documented, and presented in a regulatorily acceptable way.