In Vitro Consulting for Smarter, Safer Development
Services
Failure to adopt in vitro toxicology early in your program can lead to increased development costs, safety issues, recalls, lawsuits, market entry barriers, and lost revenue. By integrating scientifically validated in vitro methods, Roper Toxicology Consulting Ltd. helps companies make informed, risk-mitigated decisions that drive success.
NEW APPROACH METHODOLOGIES (NAMs) DEVELOPMENT OR NON-ANIMAL MODEL TESTING STRATEGIES
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Specialization in designing customized in vitro testing methods in dermal, respiratory, and innovation
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Guidance to build the most suitable model related to available technologies
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Guidance for adopting cutting-edge, regulatory-compliant alternatives to animal testing
IN VITRO SKIN ABSORPTION, IN VITRO RESPIRATORY TOXICOLOGY, 3D MODELS, AND MICROPHYSIOLOGICAL TECHNIQUES
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Identification of respiratory toxicants
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Guidance for tests and applications such as FDA bioequivalence dermal programs, efficacy & toxicity respiratory programs
EVALUATION OF IMPLEMENTED TECHNOLOGY
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Maximize the potential of your technologies and systems
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Sourcing innovative solutions for technology gaps
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Analysis of current workflows to optimize processes
REGULATORY & COMPLIANCE SUPPORT
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Navigation of regulatory frameworks across industries, ensuring studies meet FDA, EMA, and global guidelines
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Identification of potential safety risks before costly in vivo trials, improving decision-making and regulatory success
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Guidance realted to regulatory requirements & internal decision-making processes
LEGAL & EXPERT WITNESS SERVICES
• Serving as an expert witness in legal cases requiring scientific data interpretation
• Objective analysis to support toxicology-related litigation, compliance disputes, and regulatory hearings
PROJECT MANAGEMENT & CRO PARTNERHIPS
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Connecting clients with trusted Contract Research Organizations (CROs) for specialized testing needs
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Oversight to ensure scientific rigor, regulatory alignment, and efficient study execution
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Driving projects forward through study monitoring and expert insights
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Strategic support to enhance brand reputation, foster industry trust, and ensure long-term success
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Offering a network of industry experts to support clients expand their service offerings and reach the right audience
BRAND & MARKET POSITIONING
Why Roper Toxicology Consulting
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Proven expertise in identifying and solving toxicology challenges
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A collaborative approach to developing cutting-edge in vitro testing strategies
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Regulatory foresight to prevent costly compliance failures
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Commitment to the 3Rs principle—replacing, reducing, and refining animal use
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FAQs
New Approach Methods (NAMs) have a growing significance in advancing regulatory toxicology. These FAQs introduce NAMs and describe how the context of use (CoU), adverse outcome pathways (AOPs), and complex in vitro models (CIVMs) support the development of predictive, human-relevant safety assessment aligned with regulatory expectations.
What are NAMs?
NAMs refer to innovative scientific tools, technologies, and strategies that aim to replace, reduce, or refine (3Rs) the use of animals in safety and efficacy testing. “New” does not necessarily refer to a new technology but instead refers to a new way to answer a regulatory question. NAMs include complex 3D co-culture models such as MucilAir™ (upper airway), ALIsens® (alveolar airway), organ-on-a-chip (OoC), microfluidic devices (MPS), and computational models (e.g., AI and ML).
What is Context of Use (CoU) and Why Does It Matter in Relation to NAMs?
NAMs must define a regulatory context of use (CoU), the specific regulatory question the method is designed to address. Establishing a CoU helps determine the most appropriate test or battery of tests that reflect the biological mechanisms relevant to a disease or toxic response. Clearly defining the CoU ensures that the data generated is both fit for purpose and aligned with regulatory expectations.
What are Adverse Outcome Pathways (AOPs) and How Do They Relate to the CoU?
Adverse outcome pathways (AOPs) describe the biological sequence of events that lead from a molecular initiating event (MIE), the initial interaction between a chemical and a biological system, to one or more key events (KEs) that result in an observable toxic outcome. Each MIE or KE within an AOP can inform a relevant CoU and guide the design of in vitro toxicology tests. The results obtained from those tests are then brought together under an Integrated Approach to Testing and Assessment (IATA) or a Defined Approach (DA) to predict the full toxicological response. This structure allows for mechanistic understanding and regulatory confidence in the data generated by NAMs.
What is an Example of an AOP Testing Approach?
A well-established example is the skin sensitization DA (OECD TG 497). This method integrates an in chemico and two in vitro assays aligned with a specific key event (KE) within the AOP that accurately models the biological pathway of skin sensitization, providing a predictive alternative to animal testing. These assays are:
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Covalent binding to cellular proteins (KE1, OECD TG 442C)
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Keratinocyte activation (KE2, OECD TG 442D)
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Dendritic cell activation (KE3, OECD TG 442E)
What are Complex In Vitro Models (CIVMs) and How are They Used within NAM Testing Strategies?
CIVMs are advanced in vitro lab systems that combine co-cultures, multiple cell types, or connected tissues to replicate human biology. Examples include organoids, spheroids, tumoroids, OoCs, MPS, and 3D transwell models. CIVMs are important to in vitro toxicology test systems because they improve predictivity, support regulatory acceptance, and reduce the reliance on animal testing through reliable human-relevant data.