Scientific and regulatory support for drug discovery and development
We provide integrated consultancy in DMPK, toxicology and non-clinical safety, helping biotech and pharmaceutical companies make better decisions, reduce risk and accelerate development timelines.
Clear strategy for complex scientific and regulatory challenges
ADME screening and lead optimisation
Design and optimisation of ADME screening cascades from hit-to-lead to candidate selection.
- Design and optimisation of ADME screening cascades from hit-to-lead to candidate selection. Includes hit-to-lead support, lead optimisation strategy, ADME cascade design and scientific interpretation of screening data.
IND-enabling programmes
Strategic support for non-clinical packages required to progress towards first-in-human studies.
- Strategic support for non-clinical packages required to progress towards first-in-human studies. Includes IND-enabling study planning, non-clinical safety packages, FIH readiness support and CRO selection and oversight.
Development strategy
Integrated scientific support to select the right candidate and build a robust development strategy.
- Integrated scientific support to select the right candidate and build a robust development strategy. Includes candidate selection criteria, DMPK and toxicology integration, risk-based development planning and decision-making support.
Regulatory documents and agency interactions
Preparation and scientific support for regulatory documentation and interactions with agencies.
- Preparation and scientific support for regulatory documentation and interactions with agencies. Includes briefing documents, scientific advice preparation, EMA and FDA aligned strategy and response preparation.
Due diligence and second opinions
Independent scientific review for investors, biotech leadership and business development teams.
- Independent scientific review for investors, biotech leadership and business development teams. Includes licensing support, asset evaluation, portfolio review and scientific risk assessment.
Risk assessment and mitigation
Early identification of potential DMPK, toxicology and regulatory risks across discovery and development.
- Early identification of potential DMPK, toxicology and regulatory risks across discovery and development. Includes gap analysis, risk mitigation plans, exposure-response interpretation and development remediation strategy.
Specialised scientific and regulatory consultancy
Pharmacokinetics, drug metabolism and toxicology
We support programmes from hit identification through to clinical development and registration.
- ADME screening cascade design
- Candidate selection support
- Full DMPK and toxicology support
- Strategic study design
- CRO selection and outsourcing
- Expert scientific oversight
Regulatory interactions
We provide strategic and hands-on regulatory support aligned with EMA and FDA expectations.
- Clinical pharmacokinetics strategy
- Toxicology and safety pharmacology strategy
- Dose justification
- Exposure-response analysis
- DDI risk assessment
- Special population strategy
Strategic and business support
Independent scientific insight for investors, biotech leadership and business development teams.
- Due diligence for licensing and acquisitions
- Portfolio and asset evaluation
- Risk assessment and mitigation
- Board and investor discussion support
- EU/US development strategy alignment
A pragmatic, data-driven and client-focused approach
Understand
We review your scientific, regulatory and development context to identify the key challenges.
Analyse
We assess DMPK, toxicology and non-clinical safety data to identify gaps, risks and opportunities.
Strategise
We translate complex data into clear development and regulatory strategies.
Support
We provide ongoing scientific guidance, documentation support and agency interaction preparation.