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