Consultant Feedback

"When you work with him, you have access to over 20 years of strategic therapeutic product development gained in large and small Biotechnology & Pharmaceutical firms, and this is priceless."
Vice President of Research & Development, Biotechnology Company
Compliance
Our Compliance support provides consulting to ensure successful compliance with current regulatory Agency requirements. Our consulting support includes:

  • Gap Analysis of Compliance deficiencies within
    • Clinical
    • Nonclinical
    • Manufacturing
    • Quality Assurance and Control
     
  • Quality Systems Assessment
  • Advertising and Promotional Compliance
  • Labeling and Packaging Compliance
  • Regulatory Agency Inspection Preparation
     
    • Creation of SOP & Processes
    • Staff Training
    • Mock Inspections
     
  • Pre-Approval Inspection preparations
  • Facility compliance evaluations
  • Response to Regulatory Agency deficiency letters
  • CE Marketing Certification and Surveillance Inspection Reports
  • Confidential Corporate Compliance Assessments for Senior Management
  • Creation of Corporate Compliance Committees
  • Development of Corporate Compliance Reports for Senior Management
  • Due Diligence Preparations or External Assessments