Services

Quality Management

Services

Quality Management

ICQ is here for you in relentless pursuit of quality manufacturing. We work closely with your quality team to evaluate procedures, conduct compliance audits, develop risk mitigation and action plans, create efficient documentation and reporting systems, and assist with regulatory filings — all the critical activities that lead to reproducible and reliable quality production.

Together in Quality

Without quality, biopharma companies cannot deliver life-saving treatments to patients who need them. Biopharma quality teams carry a heavy burden and an even heavier workload. That’s where ICQ comes in — to help overworked quality teams develop and execute best practices to ensure patients can access medications and therapies when they need them.

Pharmaceutical Manufacturing Engineer Talks with Project Supervisor, They Use Digital Tablet Computer and Discuss Modern Factory Planning

ICQ is here for you in relentless pursuit of quality manufacturing. We work closely with your quality team to evaluate procedures, conduct compliance audits, develop risk mitigation and action plans, create efficient documentation and reporting systems, and assist with regulatory filings — all the critical activities that lead to reproducible and reliable quality production.

Together in Quality

Without quality, biopharma companies cannot deliver life-saving treatments to patients who need them. Biopharma quality teams carry a heavy burden and an even heavier workload. That’s where ICQ comes in — to help overworked quality teams develop and execute best practices to ensure patients can access medications and therapies when they need them.

ICQ in Action

Quality alignment after acquisition.

“ICQ performed an audit of our facilities, quality systems, and operational readiness and outlined a simple yet thorough executable and efficient strategy.”

Former Senior Director of Quality Assurance
Agenus

Former Senior Director of Quality Assurance
Agenus

agenus (case study heading image)

Quality and Compliance Auditing Services for Life Sciences

  • Assistance with Compliance Audits
  • Development and Management of Compliance Action Plans
  • Regulatory Readiness Inspections and Training
  • Response to Regulatory Citations and Warning Letters
  • Design of Quality Systems for New Facilities or New Process Lines
  • Ongoing QA/QC Support
  • Preparation of Regulatory Filing and Review Documents
  • Implementation of Quality by Design (QbD), ICH-Q8, ICH-Q9, ICH-Q10, ASTM E2476, and ASTM E2500 Principles and Approaches
  • GxP Performance Audits
  • Quality Risk Management
  • Quality Systems Audits

Quality and Compliance Auditing Services for Life Sciences

  • Assistance with Compliance Audits
  • Development and Management of Compliance Action Plans
  • Regulatory Readiness Inspections and Training
  • Response to Regulatory Citations and Warning Letters
  • Design of Quality Systems for New Facilities or New Process Lines
  • Ongoing QA/QC Support
  • Preparation of Regulatory Filing and Review Documents
  • Implementation of Quality by Design (QbD), ICH-Q8, ICH-Q9, ICH-Q10, ASTM E2476, and ASTM E2500 Principles and Approaches
  • GxP Performance Audits
  • Quality Risk Management
  • Quality Systems Audits

How Can We Help You Get It Done Right?