Our development experts can assist in lead candidate developability assessment. We provide a full review and development planning servicing, including milestones for early synthesis testing and early preclinical material generation. We specialise in optimizing the discovery – development interface and assist on planning for phase dependent development plans and the needed supporting documentation.
To support route scouting and process development activities and accelerate your clinical programs, we provide a comprehensive range of analytical services. Our analytical development and Quality Control teams have in-house access to a comprehensive range of state-of-the-art analytical techniques. We provide full stability studies alongside our analytical and quality control teams.
Obtaining the optimal physical form for your API is important as this impacts downstream product performance. Optimizing characteristics such as size/shape, particle size distribution, flow, density, bioavailability and melting point enables more efficient formulation and manufacturing process development at the drug product stage.
We can help in identifying formulation strategies and also design and manage critical preformulation studies such as salt screening, form screening, pH solubility studies, solubility in solvents and drug-excipient compatibility studies to help secure the best formulation candidates moving forward.