Two Partners. Two Practical Principles. One Powerful Approach.
The Practical Solutions Group, LLC
152 Witherspoon St.
Princeton, NJ 08542
P: 609.683.0756
F: 609.683.0758

Quality Infrastructure and Business Processes

  • Quality system development (e.g., GMP, GLP, GCP, 21 CFR part 820, ISO 13485)
  • FDA 483/warning letter remediation support
  • Client representation at external audits
  • Risk and operations assessment
  • Audit program design and implementation
  • Investigations/complaints
  • Quality/operational problem resolution
  • SOP review and development
  • Change control process development
  • Compliance and operations training
  • Compliance/quality problem resolution
  • QA/QC oversight: e-submissions, data migration, system integration/validation
  • CMC support