Clinical

Medical Writing Training
Regulatory Medical Writing

Manufacturing

Technical Writing & Training
Regulatory Submissions
Cursos en Español

Consulting

cGMP & CMC Consulting

Thanks to your efforts, the deviation process held up well to FDA scrutiny

cGMP and CMC Consulting

cGMP consulting, CMC consulting, CMC auditing, CAPA effectiveness, process mapping and SOP remediation Working 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