• Program and Project Management
  • Quality Management Systems
  • Cleaning Validation and Sterilization
  • Validation Process Optimization
  • Computer System Validation
  • (CMO)Contract Manufacturer Organization Third Party Selection Services
  • (GxP)Quality Systems Audits and Gap Analysis
  • Product Security: Serialization Track and Trace
  • Technology Transfer
  • Technical Writing: APR(Annual Product Reviews), Health Authority audit response, SOPs, Validation Protocols and Reports
  • Quality Assurance: Deviations, OOE/OOS, CAPA, Change Management, Interim controls and remediation

Industries Served

  • Pharmaceutical
  • Medical Device
  • Vaccines/Biologics
  • Nutraceutical