Validation Protocol Development and Execution

Process Development and Validation

  • Manufacturing Process Development and Validation
  • Process Assessment and Optimization (Design of Experiments/SPC)
  • Manufacturing Scale-Up
  • Technology Transfer
  • Technical Report Writing (Validation, etc.)
  • Equipment Qualification
  • Cleaning Validation

Software/Computer Systems Validation

  • Assessment and Remediation of Manufacturing, Laboratory, Medical Device, R&D Facilities and Equipment
  • Computer-Controlled – Laboratory Equipment
  • Database Management Systems (LIMS, ERP, MRP, MES, EMS, Doc. Management)
  • IQ, OQ, PQ Protocols

Laboratory and Analytical Support

  • Analytical Method Development and Validation
  • Cleaning Validation and Analytical Testing (Verification)
  • Equipment Qualification (IQ,OQ,PQ)
  • Stability Program Design
  • Analytical Testing

Manufacturing and Manufacturing Support

  • Cleaning Methods Development (Cleaning Validation)
  • Sterilization Cycle Development
  • Process Cycle Time Reduction
  • Barrier/Isolation Systems Design
  • Water Systems Validation
  • Aseptic Manufacturing Systems Design
  • Filling and Packaging Process Design and Validation
  • Documentation Systems Assessment and Remediation