Our Disease Areas/Therapeutic Areas

Specialised therapeutic consulting across disease areas.

Oncology Consulting

Leveraging deep expertise in advanced in vivo and in vitro cancer models, our oncology consulting supports clients in tackling the scientific challenges of drug development, from validating targets to designing combination therapies.

  • Strategic and results-oriented: Our oncology consulting helps clients navigate the complexities of cancer drug development, providing strategic guidance from target validation to planning effective combination therapies based on robust preclinical models.
  • Client-focused and collaborative: We partner with clients to address the unique challenges of oncology drug development, drawing on extensive experience with in vivo and in vitro cancer models to guide target validation and combination therapy strategies.

Cardiovascular Disease Guidance

Cardiovascular preclinical programs require precise safety pharmacology and long-term toxicity planning. We help clients design studies that reliably assess cardiac risk and efficacy against challenging endpoints like fibrosis or heart failure.

  • Specific Approach: Consulting on the optimal timing and design of safety pharmacology studies.
  • Common Pitfall Avoidance: Helping clients avoid issues related to model variability and correctly interpreting borderline safety signals.
  • Study Strategy: Designing chronic dosing studies and appropriate functional readouts for efficacy.

Neurological Disorders Strategy

CNS drug development is inherently challenging due to obstacles like blood-brain barrier penetration and complex behavioral assessments. We support well-designed, predictive studies that generate actionable data and support the efficient advancement of therapies from preclinical models to clinical trials.

  • Specific Approach: Guidance on selecting appropriate disease models (e.g., induced pluripotent stem cell models or transgenic models) and validating their endpoints.
  • Drug Delivery Focus: Strategising on bioavailability, biodistribution, and assessment of CNS target engagement.
  • Unique Insight: Our laboratory background provides direct knowledge of which behavioural and pathological assessments are most reliable in different CNS models.

Toxicology Research

Our toxicology research support services provide comprehensive expertise across all stages of preclinical safety assessment. We assist clients in designing and executing studies in accordance with OECD GLP, ICH, FDA and regulatory guidelines, covering acute, subchronic, and chronic toxicity, reproductive and developmental toxicology, and specialized safety pharmacology evaluations. By combining robust study design, meticulous data analysis, and regulatory compliance, we help pharmaceutical and biotechnology companies generate reliable safety data to support IND, NDA, and global regulatory submissions. Our team also offers guidance on study planning, test item control, data interpretation, and reporting, ensuring studies are scientifically rigorous, timely, and fully compliant. Method development for PK/TK on small molecules and biological molecules. Liaising with Pathologists and pathology services.

Comprehensive Safety Study Data

Regulatory agencies require robust preclinical safety data to evaluate potential risks. This includes acute, subchronic, and chronic toxicity studies, as well as reproductive/developmental toxicity, genotoxicity, carcinogenicity, and safety pharmacology assessments, all conducted according to GLP standards. The data must clearly demonstrate dose-response relationships, identification of target organs, and safety margins.

  • Compliance with Guidelines and Documentation: Studies must adhere to relevant OECD, ICH, FDA, EMA, or local regulatory guidelines, including GLP, Good Documentation Practices (GDP), and proper study design. Full documentation—study protocols, raw data, deviations, and final reports—must be complete, traceable, and auditable to support regulatory review.
  • Clear Interpretation and Regulatory-Relevant Reporting: Beyond raw data, regulators expect well-analyzed, clearly interpreted results with meaningful conclusions about safety and risk. This includes NOAEL/LOAEL determination, clinical relevance, and translation to human risk, often summarized in Integrated Safety Reports, Expert Reports, or Common Technical Documents (CTD) to facilitate IND/NDA submissions.

Expert and concise:

  • Technical Precision: Backed by extensive experience in complex in vivo and in vitro cancer models, our oncology consulting supports every stage of drug development — from target validation to combination therapy design.
  • Strategic Guidance: Our oncology consulting applies deep scientific insight and proven expertise in cancer modeling to guide clients through each phase of drug development, including target validation and combination therapy strategy.
  • Collaborative Expertise: With broad, hands-on experience in in vivo and in vitro cancer models, we partner with clients to solve the challenges of oncology drug development — from confirming targets to shaping effective combination therapies.

Our Expert Guidance

Navigate the complex landscape of oncology drug development with our specialised expertise.

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