Our cGMP production capabilities and extensive experience in cGMP enable us to offer a complete solution for your project requirements, including:
- Study management – a dedicated Study Manager will assist you regarding the progression of the project
- Process research and development, including process transfer – scientists working on your project will assess and improve the manufacturing process
- Analytical method development and validation – dedicated analytical scientists will optimise procedures in order to accurately identify API and related substances
- API manufacture – production scientists will manufacture the active substance to support your study, in up to multi-kg quantities
- Aseptic processing including sterile filling
- Stability testing – evaluation of active substance under a variety of environmental factors such as light, temperature and humidity
- Cold storage
- Lyophilisation