Reaching the clinic starts with good planning
Your non-clinical development programme should show the efficacy, mode of action, and toxicity profile of your drug. You need to decide which models will provide meaningful data, in what sequence the work should happen, what the regulators will expect, and where any gaps could delay or even derail your clinical trial application.
We help you answer these questions early. Working alongside your team, we build a scientifically sound, regulatory-informed, and practical development plan around your product, target product profile and intended clinical pathway.
The result is a clearer route to the clinic, with priorities defined and risks made visible before they become delays.
Specialist non-clinical support from Leads To Development
Leads To Development, part of Clarenta Group, provides specialist support in non-clinical development, manufacturing and regulatory strategy.
Its services include development planning, assessment of preclinical evidence, coordination of toxicology and pharmacology activities, manufacturing support, advice on scientific advice meetings and CTA or IND submissions. Clients can access this expertise alongside Clarenta’s clinical development capabilities.
Development strategy & planning services overview
Our team defines a bespoke, regulatory-compliant development plan tailored to your product, your strategy and your needs.
Development roadmap
Our team helps build a detailed Gantt chart showing realistic sequencing, key dependencies and estimated costs. This provides a clear view of the development timeline, budget requirements, upcoming milestones and critical decision points.
Regulatory pathway
Our regulatory experts help you develop the strategy and plans, including scientific advice and pre-IND meetings, orphan drug or fast-track designations, and CTA or IND applications. Each step is aligned with your wider development plan.
Pharmacology & toxicology
Our experts help you determine the necessary pharmacology studies and required toxicology, toxicokinetic and safety pharmacology assessments in appropriate species. Together, we establish the bioanalytical methods and testing criteria needed to generate relevant, regulatory-ready evidence.
CMC development
Our experts help you define the production scale, formulation requirements and control strategy. Working alongside your team, they align these elements with the wider development plan to support manufacturing and regulatory submissions.