Sterility Assurance CMC Review

Sterility assurance is critical to patient safety and to the successful submission of an application to CDER or CBER. Dr. Ken Muhvich, former CDER Microbiologist, currently provides consultancy to sterile drug and biologics manufacturing companies regarding submission of sterility assurance validation packages to be included in NDAs, ANDAs and BLAs.

After reviewing a specific sterility assurance validation package [SAVP], we will provide a letter to the client describing our findings, comments, and recommendations for improvement of the validation package before submission to the FDA.

NOTE: Should the client specifically follow our recommendations and directions, Dr. Muhvich will provide continued support at no cost or gratis.

Review and comment on a sterility assurance validation package will be billed as a lump sum cost [flat fee]. Cost for review of a SAVP for a product that is manufactured using aseptic processing will be somewhat higher than for a product that is terminally sterilized using moist heat. Please contact us for details on our reasonable fixed pricing and SAVP consultancy.