API for early use is produced at state-of-the-art manufacturing facilities. We can supply both cGMP and non-GMP material to support your needs. A team of experts will surround your project with a full range of technologies. The supply of materials is fully supported by analytical services and we pride ourselves for on time delivery.
API for early and late-stage trials will be manufactured at our cGMP commercial production facility that supports a wide range of scales that are available to meet your needs and keep your costs in line. Our team of experts will work continuously to optimize processes, increase outputs and reduce timelines.
Scale up will include risk assessment and proven acceptable range studies, as well as validation of analytical methods and the manufacturing process. Our QA/ regulatory and validation compliance team will provide data and support for the CMC portion of your submission. All our facilities comply with cGMP regulations and are regularly inspected by national regulatory agencies.
As part of the establishment of your commercial supply of API, Magle Chemoswed provides a complete validation package according to regulatory and cGMP guidelines. We have a highly successful and established program to ensure you’ll have everything you need to secure reliability of your supply with consistently high quality.
Hans has been with the Magle Chemoswed organization since 1978 and has held numerous positions in both production and research and development. He is currently our Development Manufacturing Manager.