Pharmaceutical > Regulatory Compliance

  • Regulatory strategies
  • Compliance Audits, Assessments, and Gap Analyses
  • FDA "mock" inspections for GMP, GLP, and GCP environments
  • Warning Letter Remediation Services
  • Preparation of responses to FDA 483, citations, and warning letters
  • Audits for 21 CFR Part 210/211, 110, 107/108, and Vendor Audits
  • Computer Systems Audits and Part 11 Assessments and Remediation
  • FDA regulatory submission preparation/review
  • Preparatory pre-approval inspection audits
  • Preparation for FDA meetings and advisory meetings