top of page

Quality and Regulatory Compliance

“Quality is everyone's responsibility.”


                           -W. Edwards Deming

We can help you build a culture of compliance


Building the right culture can be just as important as solving individual problems. We can mentor and coach your c-suite and executives to help build a culture of support for supply chain excellence and break down silos within companies or around the world. What separates us is the storytelling. We have a myriad of examples, based on our experiences, that make for memorable content that people can relate to their own situations.


Quality oversight and audit preparedness  - on or off site -

  • Audits

    • Vendor

    • Internal

    • GMP, GCP, GLP, GDP, etc.

    • QP


  • Preparation of Quality Manual, Policy, Mission, etc.


  • SOPs

    • Developments/improvements

    • GAP analysis

    • SME inputs for review and approval, & accreditation

    • Evaluation of current SOPs

    • Quality assurance review and approval....meaning we will be your Quality sign-off for SOPs etc if needed.


  • Monitor Manufacturing, packaging, labeling, review and approve label text & proof approvals


  • Batch record review/generation


  • Investigational product release


  • Risk assessment – supply chain

    • FMEA Failure Mode and Effects Analysis


  • Complaint management system/support


  • Root cause analysis


  • CAPA System Corrective Action/Preventative Action


  • Risk management program


  • PQMS - Pharmaceutical Quality Management System


  • Quality/Technical agreements


  • Validation – equipment validation, facility and process


  • Temperature control, mapping, and monitoring


  • Regulatory – Reduce Regulatory Risk

    • TMF/DMF assessment & gap analysis (Trial Master File / Drug Master File)

    • PAI  (Pre-approval inspection) presence, readiness and response support current and post

    • Inspection readiness, training and coaching




IDS Support

Bring us in when…​

  • An IDS audit has ended with multiple findings​​​...



Why and How To Interactively Facilitate Workshops...


Training and Education

Building the right culture can be just as important as solving individual problems. We have an energizing...


bottom of page