Services

Project & Crisis Management

  • Quality Assurance/Quality Systems
  • Quality Control
  • Regulatory Affairs CMC
  • Regulatory Compliance
  • Regulatory Action Remediation

Regulatory Consultation & Technical Writing

  • Chemistry, Manufacturing, and Controls (CMC) section of
    • Investigational New Drug Application (IND)
    • New Drug Application (NDA)
    • Biologics License Application (BLA)
  • Drug Master File (DMF) development, amendments and annual updates
  • Post-Approval Change (PAC) supplements to NDA, ANDA, or BLAs
  • US Agent to Foreign API and Drug/Biotech/Biological Product Manufacturers/Suppliers
  • Regulatory and CMC related sections of Briefing Packages for FDA Meetings

Regulatory Compliance

  • GMP Audits (Supplier, Manufacturer, Distributor)
  • Regulatory Action Remediation (483s, Warning Letters, Consent Decrees)

Training

  • Regulatory Authority Inspections
  • Meetings with Regulatory Authorities
  • Good Manufacturing Practice (GMP) regulations