We integrate existing data, in silico approaches and qualified non-animal methods into nonclinical strategies acceptable to regulatory agencies.
Regulatory agencies are increasingly open to non-animal methods and existing data to support safety decisions. ICH M3(R2) and other guidelines already provide for weight-of-evidence approaches.
For industry, this means the opportunity to avoid redundant studies, reduce costs and timelines, and advance the commitment to the 3Rs (replacement, reduction and refinement of animal use).
Not every toxicological endpoint can be answered today without animal studies, and many methods are not yet accepted for every regulatory use. Using NAMs without criteria can generate data that do not convince the agency and delay the program. The value lies in knowing where each approach applies, how to combine them and how to justify the choice.
Each step can be contracted separately or as a complete project.
A structured review of the literature, public databases and the client’s internal data, assessing the quality and relevance of each piece of information.
Analysis of whether computational models and data from analogous substances can answer questions without new studies.
A comparison between the available evidence and the regulatory requirements, with a roadmap of the assays that are truly needed, prioritizing qualified non-animal methods.
Tailored data generation with partner laboratories and CROs: protocol design, scientific oversight of execution and critical reading of the results.
Study reports, weight-of-evidence rationales, waiver justifications and CTD nonclinical modules.
FIH
Definition of the minimum set of nonclinical evidence needed to start studies in humans, prioritizing published data and qualified non-animal methods, with a scientific rationale aligned with ICH M3(R2).
Deliverables
Waivers
Scientific rationales that show, based on existing evidence, why a specific study is not needed, for inclusion in regulatory submissions or in responses to agency questions.
Deliverables
Final acceptance rests with the regulatory agency; D-Sci’s work is to build the strongest possible scientific justification.
For cosmetics and ingredients, we design animal-free testing strategies for eye irritation, skin irritation and sensitization based on OECD guidelines, including CRO selection and the interpretation of test reports.
See services for cosmeticsRedundant studies removed from the timeline.
Investment focused on the assays that make a difference.
A real commitment to the 3Rs.
Documented, traceable rationales.
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