How to access preformulation studies that ensure flexibility and a streamlined supply chain.
Building a robust strategy for early phase preformulation studies will enable you to drive efficiencies as you scale. Our formulation experts will provide you with fully integrated and customizable solutions that will drive speed, flexibility and a streamlined supply chain. Gain access to an integrated drug preformulation program for flexible and tailored solutions to:
- Accelerate your project to First-in-Human (FIH) studies
- Rapidly characterize your drug substance
- Quickly evaluate formulation options
- Overcome formulation challenges such as low bioavailability
- Gain a clear view of your path through preclinical and clinical studies
- Design, validate, and implement analytical and process methodologies
- Generate the data required for IND filings
Commercial manufacturing analytical solutions:
- In-process control production support
- Release testing
- Stability testing for various ICH climatic zones
- Genotox studies
- PAR studies
- IND/IMPD dossier support
You will have access to a range of formulation and analytical capabilities to take your molecule from pre-clinical to commercialization. Each of our development and manufacturing sites has cGMP labs staffed by highly experienced scientific teams. Our oral solid dose preformulation solutions include:
- Chemical purity analysis
- Physicochemical properties
- Solid form definition and analysis
- Excipient compatibility testing
- Amorphous vs. crystalline solid-state testing
- Aqueous and solvent solubility
- Solution and solid-state stability
- Vehicle screening for ADME and toxicology
