ICQ Quality Systems

Intelligent, risk-based quality strategies grounded in ICH-Q9/ICH-Q10 and otherQuality2 regulatory guidelines are being used throughout the industry to ensure product safety and regulatory compliance, while maximizing operational efficiency.

Our Compliance Specialists have an in-depth understanding of manufacturing operations, processes and systems, and are expert in the latest regulatory directions and industry best practices. As a result, we’re able to help you apply a scientific quality risk management (QRM) approach at every stage of your process—from design of unit operations, to identifying critical inspection and testing points, to developing SOPs, training and documentation.

Quality Systems services

  • 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-Q9, ICH-Q10, ASTM E2476, ASTM E2500 principles and approach