|
ReMA™ is Coderant's proprietary Regulated Manufacturing Application. This application is specific to tracking all aspects of manufacturing and delivery. ReMA™ bridges the data gap between clinical development, scale-up, and commercial development. It is built in modules that capture data relevant to the following areas:
- clinical quantity development
- scale-up methodology
- commercial manufacturing
- order-entry distribution
A fifth module is under development to track adverse event and long-term sales and distribution activity.
|
ReMA™ was originally designed around a contract manufacturing model where the manufacturing and materials management functions occur on a number of sites. ReMA™ is web-enabled and built with redundancy and security features that meet or supercede those required by the FDA and the UK's Medicines Control Agency.
|