What is a Regulatory Support File (RSF)?
A Regulatory Support File is a document containing both proprietary and non proprietary information concerning one or more related products marketed by GE Healthcare. The file may include information on performance, stability, extractable compounds and analytical methods. It is and invaluable starting point for process development and validation, for preparation of Standard Operation Procedures and quality control, and as support for clinical and marketing applications to regulatory agencies. RSF are continuously updated with new information. When the RSF to which you subscribe is updated, you will receive an e-mail that new information is available. A single payment per RSF is charged at ordering.
