Regulatory Understanding
- HANDS-ON EXPERIENCE with all regulatory agencies including FDA, DEA, MHRA, ATF, Controlled Substances (CII – CIV)
- ASSIST WITH ALL REGULATORY ASPECTS of clinical trial supplies from early PI up to and including PIV
- PERFORM RISK ANALYSIS across entire business enterprise with recommendation for remediation
- LEAD YOUR TEAM through an equivalency building session to augment change controls for CBE reporting
- DEVELOP APPROPRIATE REGULATORY ASSESSMENT of change control for submission