Regulatory Affairs and Quality Assurance

• Import/Export Services
• DEA Licensed Bonded Agent Services
• Available FDA and DEA Liaison Consulting Services
• Meets Requirements of Designated Agent as per Guidance Established by the FDA
  (February 11, 2002)
• Support Agency Regulated Submissions and Mock Pre-Approval Inspections (PAI)
• Meetings with Agencies (FDA, DEA)
• Review Process Changes for Necessary Updates to Current Submissions
• QA Systems/SOP Development, Inspections and Audits
• Document Preparation
• Literature Support and Review Validation
• Protocol Development
• Regulated Documentation Submissions Support Services
• Review Replies to FDA