cGMP and CMC Consulting

cGMP consulting, CMC consulting, CMC auditing, CAPA effectiveness, process mapping and SOP remediationWorking Words consultants have extensive backgrounds in industry; most have many years’ experience in manufacturing and Quality in major global pharmaceutical and biopharmaceutical companies.

Some of the areas in which our consultants work with our client companies are:

  • Quality System Development and Remediation (including responses to FDA Warning Letters and 483s)
  • Investigation (CAPA) System Remediation (overdue investigations, OOSs, forms, processes)
  • CAPA Effectiveness
  • Writing Regulatory Submissions (INDs, NDAs, BLAs)
  • CMC Auditing
  • Process Mapping and SOP Remediation
  • Lean Six Sigma-Based Process Improvement
  • Laboratory Systems and Procedures
  • Validation and Change Control
  • Documentation Mentoring and Coaching