Comprehensive preclinical solutions that optimize formulations during the earliest developmental stages of a new drug product.
The rapid response process assesses the solubility and short-term stability of the drug using minimal active pharmaceutical ingredients (API), ahead of efficacy, pharmacokinetic (PK) and toxicological preclinical studies.
Our solution
We provide cost-effective screening platforms using solvents and/or excipients that are tailored to each API, taking into account key aspects such as indication, route of administration and intended species. We include PK assessments in the service, enabling formulation comparisons and PK/dose prediction modelling.
Our screening capabilities are able to fast-track reformulation for bioequivalence studies for APIs that are being considered for a new indication or different patient group. Alongside solubility and stability assessments, gap analysis can be conducted to review existing work and literature data. From this a formulation and analytical development strategy is created, based on the properties of the API and its intended use.
Benefits
- Global network of experts
- Access to the latest technologies
- State-of-the-art testing facilities
- Fast-track solutions
We are recognized as the benchmark for quality and integrity. Wherever you operate in the world, we support you at every step of your product’s development – from raw materials to end product. Whatever your preclinical formulation requirements, we have the expertise to help you deliver safe, effective and compliant products to global markets.