Regulatory Affairs

Ferndale Contract Manufacturing is dedicated to meeting the highest standards in Development, Manufacturing, and Quality. These standards have produced a record of excellence in Regulatory Affairs. Our extensive knowledge and experience in this department allows us to take a proactive approach to preparing our clients for submissions to regulatory agencies.

  • Assist with oversight of cGMP compliance
  • Review of label compliance
  • Create and publish eCTD for NDA, ANDA, or IND submissions
  • Generate SPL
  • Write and compile Annual Reports