FDA Compliance

• Form 483 and Warning Letter responses
• Remediation plans
• Mock pre-approval audits
• Vendor audits
• Due diligence
• Regulatory submissions review
• Regulatory submissions review
  • - Sterilization process validation
• Strategic advice to senior management
• GMP training for employees
  • - cGMP
  • - Good documentation practices
  • - Aseptic processing
  • - FDA inspection readiness
  • - Regulatory trends