Services

Regulatory Inspection Readiness

Services

Regulatory Inspection Readiness

When regulatory inspections can happen unannounced at any time, your facility has to be in a constant state of preparedness. Passing these quality inspections each and every time is make-or-break for your company’s performance and ability to deliver life-saving and life-altering medications.

Always Be Prepared

Robust internal quality management processes — including proactive change management, risk management, and corrective action plans — will give your facility leaders confidence in passing any regulatory inspection.

Inspection readiness can help you avoid some of the most common warnings and citations related to:

  • The absence of written procedures
  • Procedures not fully followed
  • Deficient cleaning or maintenance procedures
  • Incomplete production, control, laboratory, or component test records
  • Deficient environmental monitoring systems
  • Documentation and data integrity issues
FDA Regulatory Inspection Readiness

When regulatory inspections can happen unannounced at any time, your facility has to be in a constant state of preparedness. Passing these quality inspections each and every time is make-or-break for your company’s performance and ability to deliver life-saving and life-altering medications.

Always Be Prepared

Robust internal quality management processes — including proactive change management, risk management, and corrective action plans — will give your facility leaders confidence in passing any regulatory inspection.

Inspection readiness can help you avoid some of the most common warnings and citations related to:

  • The absence of written procedures
  • Procedures not fully followed
  • Deficient cleaning or maintenance procedures
  • Incomplete production, control, laboratory, or component test records
  • Deficient environmental monitoring systems
  • Documentation and data integrity issues

ICQ in Action

It had to be perfect, the first time.

“ICQ produced extraordinary results by maintaining 100% right-first-time metrics, helping to end the consent decree and completing all assigned scope one month early.”

Jim Rice
Former Sr. Director, Facilities & Engineering
Genzyme (now Sanofi)

Jim Rice
Former Sr. Director, Facilities & Engineering
Genzyme (now Sanofi)

Sanofi Genzyme (case study heading image)

Regulatory Inspection Readiness Services

  • Quality Management Programs
  • Quality Risk Management
  • Change Management Procedures
  • Corrective Action Planning and Execution
  • Ongoing Validation Efforts
  • FDA Inspection Readiness
  • GMP Inspection Readiness
  • EMA Inspection Readiness
  • Pre-Approval Inspection (PAI) Preparation Consulting

Regulatory Inspection Readiness Services

  • Quality Management Programs
  • Quality Risk Management
  • Change Management Procedures
  • Corrective Action Planning and Execution
  • Ongoing Validation Efforts
  • FDA Inspection Readiness
  • GMP Inspection Readiness
  • EMA Inspection Readiness
  • Pre-Approval Inspection (PAI) Preparation

How Can We Help You Get It Done Right?