Regulatory Services

Our Comprehensive Package of Regulatory Services:

  • Preparation of FDA Investigational New Drug (IND)/CMC Packages and Equivalent Documentation for International Regulatory Agencies
  • FDA Pre-IND Meeting Packages
  • Manufacturing Batch Record Review and Approval
  • Preparation of GLP Documentation Packages
    • Raw materials specifications
    • Customized Batch records
    • Customized SOPs
    • Customized Quality Assurance SOPs
    • Customized, development stage specific Quality Control SOPs
    • Customized and off-the-shelf Assay validation
    • Customized Product lot release testing
  • GMP/GLP Documentation
  • Consultation for and Support with FDA and other International regulatory agency¬†Interactions
  • Vendor Selection and Auditing