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


Looking for help from an experienced pharmaceutical consultant?

To discuss your next project contact Joe Baker by phone or email.

JLBaker Consulting

Summerville, SC or Ogden Dunes, IN 801.703.8327