Regulatory Documentation Portfolio:

  • Qualification Risk Assessment
  • All department SOP’s & Formats
  • Research and Development
  • Product Development Lab
  • Technology Transfer Department
  • Analytical Department
  • Corporate Quality Assurance
  • Plant Quality Assurance
  • Quality Control
  • Microbiology Department
  • Production department
  • Engineering Department
  • Maintenance Department
  • Ware House Department
    • Raw Materials Ware House
    • Finished Goods Ware House
  • Distribution Finished Goods
  • Analytical Development Protocol Report
  • Lab Scale Batch Report
  • Pilot Scale Batch Report
  • Technology Transfer Dossier
  • Risk Base Approach
  • Protocol and Report
  • Scale –up Batch Record
    • Protocol and Report
  • Exhibit Batch record
    • Protocol and Report
  • Process Validation
    • Protocol and Report
  • Process Equipment Cleaning Validation
    • Protocol and Report
  • Facility Cleaning Validation
    • Protocol and Report