The formulation development process ensures that the medicine to be manufactured is physically and chemically stable and will continue to be so throughout its life. The formulations must also be bioavailable and comply with regulatory requirements and quality standards to ensure patient safety.
Investigation and development
Our experts are proficient in all CMC activities required for the development of novel and generic drug products and specialize in the following areas:
- Pre-formulation and formulation development
- Drug/excipient/packaging compatibility
- Early stage stability studies for active drug substances and product formulations
- Clinical manufacturing (phase I and phase II)
- Microbiological development and QC testing
- Stability indicating assay development, method validation, and forced degradation studies
- Full stability storage and testing
- Technology transfers