Welcome to Red Oaks Hill Nonclinical Consulting

Tailored Solutions for Nonclinical Development

Pragmatic Solutions for Nonclinical Development

Independent scientific expertise supporting pharmaceutical and biotechnology companies through every stage of nonclinical development. We provide strategic nonclinical strategy, safety and regulatory consulting advice that reduces development risk, meets global regulatory expectations and enables confident progression from discovery through First-in-Human studies, clinical development and beyond.

Our expertise spans small molecules, biologics, cell and gene therapies across a broad range of therapeutic areas, including oncology, neuroscience, respiratory, dermatology, ophthalmology, renal diseases, and metabolic and hematologic disorders.

We work collaboratively with clients to develop pragmatic, science-led strategies tailored to the unique challenges of each programme.

Our Services

From early discovery to registration, we provide strategic nonclinical expertise grounded in industry, consultancy and regulatory experience.

Nonclinical Strategy

We help develop tailored, science-driven nonclinical strategies to support programmes from discovery through First-in-Human studies, clinical development and registration. Advice is aligned with global regulatory expectations and designed to minimise development risk while providing adaptable strategies to meet project timelines.

Expert Scientific Advice

We can provide independent scientific input to support critical development decisions, programme troubleshooting and complex nonclinical challenges. We provide practical, evidence-based recommendations tailored to the specific needs of each development programme.

Study management and oversight

We can provide oversight of non-GLP and GLP toxicology and safety pharmacology studies, from study design and vendor selection through protocol review, study monitoring, data interpretation and final report review. We help ensure studies are scientifically robust, efficiently executed and fit for regulatory purpose.

Gap analysis and due diligence

We can provide independent review of existing nonclinical data packages to identify potential risks, development gaps and opportunities. Where required, we can develop a comprehensive nonclinical plan to address gaps to make the data package more robust and improve likelihood of gaining regulatory agency approval. We can provide scientific due diligence to support investment decisions, licensing activities, portfolio assessments and programme optimisation.

Regulatory documentation

We can prepare and/or critically review nonclinical sections of regulatory documents, including INDs, CTAs, BLAs, NDAs, Investigator’s Brochures, briefing packages and nonclinical overviews. We deliver clear, scientifically robust documentation that supports high-quality regulatory submissions.

Health Authority Interactions

We can provided strategic support for interactions with regulatory authorities, including preparation of briefing documents, review of scientific questions, development of response strategies and meeting preparation. Drawing on extensive experience in both regulatory assessment and pharmaceutical development to help clients communicate effectively with global health authorities.