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