Method development and validation

Solvias has considerable experience in developing analytical methods throughout the entire drug lifecycle. Initial tests are performed and formally validated following ICH guidelines, including preparation of validation protocols and reports. We adapt validation programs in line with your quality requirements and development stage to provide the most cost-effective solution.

Applications include:

  • Quality Control of APIs, starting material, intermediates, finished products
  • Stability testing
  • Substance characterization
  • Formulation development
  • Cleaning validations
  • Packaging material testing, especially for extractables and leachables
  • Health, Safety and Environment
  • Specialized applications and troubleshooting

Methods developed at Solvias can be readily applied to perform routine analyses in house or alternatively can be transferred. If required, we also offer training at your facilities.