Analytical Method Development & Validation
Almac provides method development and validation services for both API and drug products. These deliver analytical support in:
- Process development
- Pre-formulation
- Formulation development
- Stability
- Release testing
Our dedicated team of analytical chemists offer a unique blend of experience, expertise and focus to deliver reliable, information-rich methods to meet your exact requirements.
Working closely with clients, Almac delivers reliable and efficient stability-indicating methods. Use of automated method development software and emerging chromatography technology - such as UPLC™ - reduces method development times, providing smart separation solutions for the 21st century.
Validations are under cGMP in compliance with ICH guidelines. The use of Empower 2 Method Validation Software allows us to streamline the method validation strategy. This brings the benefits of minimised time and cost for the validation process, whilst generating accurate and reliable data. |