Documents


  •  Equipment and process qualification protocols and reports
  •  Process and cleaning validation protocols and reports
  •  Method development protocols and reports
  •  Stability protocols and summaries
  •  Technology transfer plans and reports
  •  Investigation reports
  •  IND and NDS (Chemistry, Manufacturing and Controls)
  •  Drug master files
  •  Master production records
  •  Standard operating procedures
  •  Clinical evaluation reports, post-market surveillance reports and literature reviews
  •  Training presentations
  •  Data and project presentations