Mechanistic insight, regulatory credibility, and optimised testing strategies for the chemical and related industries.
New Approach Methodologies (NAMs)
Integrating NAMs into Modern human health and environmental toxicology, hazard and risk assessment
The Need for NAMs
Why new approach methodologies are essential for modern chemical safety assessments.
Growing social and political pressure is accelerating the shift away from animal use in chemical safety assessments. New Approach Methodologies (NAMs) have long contributed to understanding toxicological effects, and with more than 60 years of accumulated toxicology expertise, they now offer meaningful solutions to environmental fate and (eco)toxicology challenges.
NAMs have strong potential to advance the 3Rs, Replacement, Reduction and Refinement, but realising this potential requires a significant transformation in how safety assessments are performed.
Mandatory regulatory studies, such as 28- or 90-day repeated-dose, reproductive, or developmental toxicity tests, can generate findings that influence a substance’s classification, labelling, risk assessment, and ultimately its permitted uses. When classification outcomes are critical, NAMs can play a valuable role in clarifying mechanisms of toxicity and supporting a strong regulatory position. In particular, they can help demonstrate when certain effects may not be relevant to humans, providing important context for decision-making.
Our Services
QSARs
Our QSAR services use advanced computational modelling and leading tools to fill data gaps and assess potential chemical hazards across key environmental and human health endpoints. By staying aligned with the latest scientific and regulatory developments, we deliver robust, defensible predictions that strengthen hazard identification and risk assessment.
What We Do
Implementing NAMs-based strategies for regulatory and scientific confidence.
At Penman Consulting, we help drive this transformation by advancing chemical safety through responsible, science-led approaches aligned with the 3Rs.
Although animal testing may remain a last resort for ensuring safety, we specialise in developing robust, alternative strategies grounded in fit for purpose application . Our work goes beyond meeting regulatory obligations; it reflects our commitment to applying innovative and ethical methodologies.
Our experts are deeply engaged in scientific and regulatory communities, ensuring that NAMs are implemented in ways that are both practical and credible. These methods are integrated into client strategies to enhance both ethical alignment and regulatory acceptance.
The Challenge
Regulatory barriers limit the use of NAMs in chemical safety assessment.
Despite advances in NAMs regulatory frameworks limit their use. Under REACH, NAMs cannot replace mandatory animal studies but can support scientifically justified read-across strategies if rigorously designed.
Many NAMs also lack validation for regulatory endpoints and may not reliably achieve intended predictive or mechanistic outcomes, limiting their practical application. Regulatory authorities generally accept NAMs only in a supporting role, where they can enhance read-across rationales and contribute to the reduction of animal testing, but at this time, they cannot serve as a substitute for legally required studies.
The Solution
How Penman Consulting delivers regulatory-ready NAMs strategies.
At Penman Consulting, we help clients harness the full potential of NAMs to generate scientifically robust, regulatory-relevant data.
Expert NAMs Guidance
We navigate the rapidly expanding landscape of NAMs, advising on which methods are most likely to provide meaningful data to support hazard and risk assessment.
Strategic Integration
We design and implement NAM-based strategies, including both animal and non-animal approaches, integrating results into existing dossiers and supporting regulatory acceptance.
Tailored Data Generation
Leveraging strong partnerships with laboratories providing high-quality NAM services, we support bespoke study design to generate relevant, fit-for-purpose data.
Regulatory-Ready Application
Our track record demonstrates successful NAM applications in read-across and targeted toxicological evaluation, reducing both animal use and testing costs.
The Result
Achieving efficient, and ethical safety assessments with NAMs.
Penman Consulting enables regulatory-ready, scientifically robust safety assessments supported by NAMs. Our strategies strengthen read-across, reduce animal testing, and streamline hazard and risk evaluation, delivering efficient, cost-effective, and ethically responsible outcomes.
Why choose us?
Expert NAMs guidance that strengthens regulatory outcomes
We provide expert, practical solutions that add real value to chemical safety assessment:
Strategic NAMs selection
Careful identification of appropriate fit for purpose NAMs to support regulatory hazard and risk assessments.
Bespoke Study Design
Development and implementation of tailored animal and non-animal studies to enhance mechanistic understanding, human relevance, and support CLP, REACH, human relevance, and weight-of-evidence evaluations.
Reduction of Animal Use
Designing approaches that help meet social and political objectives for minimising animal testing in chemical safety assessments across Europe.
Our NAMs Experts
Specialists in regulatory toxicology, mechanistic science, and NAM integration.
Whether supporting dossier development, interpreting complex datasets, or designing targeted testing strategies, our experts deliver clear, defensible science that supports regulatory acceptance and drives efficient decision-making.
Larry Higgins
Head of Scientific Services
Claire Elliott
Principal Toxicologist
Audric Mathuren
Exposure Scientist
Alexia Pelloux
Environmental Scientist
Katy Wilson
Toxicologist
Kayleigh Coates
Toxicologist
Marek Pipal
Toxicologist
Jan Maarten Teuben
Head of Product Stewardship & Strategic Initiatives
Take Action Today
Don’t let critical hazard or risk observations jeopardise your substance or compound.
Partner with Penman Consulting to safeguard your products and optimise compliance.