Pharmaceutical and Medical Device Consulting

  • Independent Compliance Audits
  • Response to FDA 483, Warning Letters
  • Quality Assurance Systems
  • Quality Manuals, SOPs
  • Master Validation Plans
  • IQ, OQ, PQ Development
  • Remediation Plans
  • 510(k) preparation
  • US Agent services
  • Regulatory Affairs


expert - sustainable - affordable


Medical Device and Pharmaceutical industry veterans are ready to help you comply with FDA and ISO 13485 requirements for manufacturing, quality assurance and process validation