Regulatory Approval

Our Client: Chemistry and Manufacturing Controls (CMC), a start up company, engaged Safis to act as their regulatory affairs function as well as to develop a solution to change manufacturing processes to remove ASMs.

Safis deliverables for regulatory affairs:

• Defined CMC regulatory strategy
• Defined control strategy
• Prepared pre-IND briefing document
• Organized and attended the FDA meeting
• Prepared module 3 for IND

Safis deliverables for ASM removal:

• Consult on regulatory aspect of ASMs
• Interface with FDA regarding protocol review
• Review and consult on protocol edits
• Protocol ready for submission in December eCTD