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.

         
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