ARC’s work spans five service areas, each grounded in scientific judgment and shaped by an understanding of how data needs to function in real development, regulatory, and investment decisions.
Decisions about impurities, degradation products, and exposure thresholds rarely sit cleanly inside a single guideline. They sit at the intersection of chemistry, toxicology, manufacturing reality, and regulatory expectation — and the right answer often depends as much on how a question is framed as on the data behind it.
ARC supports teams working through these questions with structured, evidence-driven assessments and clear scientific rationales that hold up under regulatory scrutiny.
Sponsors and developers navigating CMC changes, impurity profiles, formulation decisions, or regulatory questions where the available data needs to be interpreted, contextualised, and defended.
ERA is a defined regulatory requirement across multiple regulated products and substance categories, which is rarely a routine exercise. Data gaps, legacy substances, and questions about study relevance all require scientific judgment, not just compliance.
ARC delivers ERA work that meets regulatory expectations while keeping the underlying science transparent and defensible.
Organisations developing or maintaining regulated products for which environmental considerations form part of development or regulatory decision-making.
Non-clinical development is rarely limited by the availability of studies. It is however limited by how well the evidence supports the decisions that follow. ARC helps sponsors build scientifically robust development programmes by providing independent advice on strategy, study design, evidence evaluation, and regulatory readiness.
Organisations requiring an independent assessment of non-clinical evidence, development risks, and regulatory readiness to support critical development and investment decisions.
Early development decisions have long shadows. Choices about experimental design, chemistry, formulation, route, and process made in the first phases of a programme shape what is possible and what is defensible, much later in the lifecycle.
ARC works with teams that want early experimental and development choices to anticipate the scrutiny they will face later, whether regulatory, operational, or investor-related, rather than discover critical issues at a later stage.
Programmes at early or mid-stage development, pharmaceutical and biotechnology companies, innovators and development teams.
Academic research produces scientific capability. Translating that capability into something an industrial partner can evaluate, commission, or build on requires a different kind of thinking; one that starts from industrial expectations and works backward into what needs to change, not from the science outward.
ARC works with research institutions and core facilities that want to bridge this gap: either by structuring their existing capabilities into credible, repeatable service offerings, or by designing new research programmes that anticipate the regulatory, quality, and market conditions their outputs will eventually face.
Research institutions, universities, research infrastructures, public-private partnerships, and consortia seeking support with research strategy, proposal development, consortium building, research infrastructure engagement, and impact planning.
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