Regulatory Science Strategies
Unlocking innovation through responsible practices.
Introduction
We take a pragmatic approach to regulatory compliance, considering factors such as reducing cost and time for subsequent market access, and avoids or minimises the need for testing in laboratory animals to generate required chemical hazard data.
We can provide this because of the deep and diverse expertise we have in our team, and we apply this at all stages in the process: from informed decision-making on the most optimal registration strategy, to developing staged testing strategies which apply targeted testing combined with Read Across supported by New Approach Methodologies (NAMs) – which include in-vitro screening assays, mechanistic studies or in-silico models.
Our experts have developed their extensive experience in developing these NAMs from working in biotech companies, other research institutes and by continuous development for our clients, continuing to be actively engaged with the relevant authorities. We know what works and what does not (yet), and how to practically apply them in the strategies we develop, as discussed in the section about “Next Generation Risk Assessment”.
New Approach Methodologies (NAMs) Services
At Penman Consulting, we recognize the imperative to advance chemical safety while promoting the advancement of the three “R’s” (Replacement, Reduction and Refinement of testing).
Acknowledging that, at times, laboratory animal testing becomes a necessary last resort to ensure safer chemicals, we stand at the forefront of change. As experts in the field, we specialize in pioneering alternative testing strategies rooted in New Approach Methodologies (NAMs).
Our commitment extends beyond ‘just’ regulatory compliance and innovation—it’s about responsible science. Our experts have a longstanding active engagement in the scientific and regulatory communities, through which we ensure a realistic application of New Approach Methodologies (at Penman Consulting, we support the OECD working definition stating that a NAM is everything that is not an ‘old approach’, not exclusively ‘non-animal’, but is aligned with the 3Rs. We apply all of them in the strategies we develop for clients, separately or integrated, as will be further elucidated in the example below. The way we approach this not only aligns with ethical considerations and the values we stand for as a company, but also significantly enhances the likelihood of success in gaining acceptance for these cutting-edge strategies for our clients.
Join us on the journey toward safer, more sustainable chemicals without compromising our commitment to compassion and progress. At Penman Consulting, we are not just helping to shape the future; we’re doing it responsibly.
Hans Ketelslegers (Head of Regulatory Affairs):
“Our aim is an ‘intelligent compliance’ approach for our clients, where we always look for opportunities to incorporate the newest technologies and approaches into the regulatory science strategies we develop.
This advances the 3R’s principles and speeds up time to compliance while reducing cost for our clients“
Case Study
Grouping and read across is the most commonly applied alternative approach to animal testing under the EU REACH regulation. However, for highly complex substances such as substances of Unknown, Variable nature, Complex reaction products of Biological origin (so-called UVCBs), this is not straightforward and current regulatory guidance does not provide practical solutions.
One way to address this, is to add a layer of biological similarity on top of the chemical composition to facilitate Chemical-Biological grouping and read across, to eventually minimize the need for and avoid unnecessary animal testing. One example of a New Approach Methodology called “metabolomics” provides the data to support such strategy.
Our experts at Penman Consulting, together with member company experts in the LOA Consortium, lead an international research collaboration to generate these data and apply them in a regulatory context to support the consortium’s REACH dossiers.
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