Analytical development and validation
We underpin formulation development and clinical manufacture by providing comprehensive analytical support and validation, based around current ICH guidelines. Our experienced team of analysts are also trained to look beyond the SOPs for the smallest detail and nuances that may impact the development and stability of your product.
Our services typically include:
- Preformulation analytical testing
- Assay / related substances method development and validation
- Cleaning method development and validation
- Excipient compatibility
- Moisture determination by LOD
- Dissolution testing and content uniformity assay
- Forced degradation – assay / related substances
- ICH stability testing and monitoring