Quality Assurance

Widely recognised for having one of the most comprehensive Quality Assurance Programs in the industry, ICON Development Solutions' Bioanalytical Group has enjoyed a strong regulatory track record with both the FDA and our clients.

As an organisational entity that is separate from operations, our on-site QA staff can effectively assess the quality and integrity of the total work product. During these assessments, any significant inspection observation is immediately communicated to senior management. And while the QA Department is an independent entity, the members serve as consultants to scientists and managers who are continually improving our systems, processes and procedures.

Every QA staff member employed at ICON Development Solutions goes through a comprehensive training program involving practical hands-on mentoring for inspection experience, as well as formal training in:

  • Good Laboratory Practice (GLP)/current Good Manufacturing Practice (cGMP) regulations
  • Good Clinical Practice (GCP) regulations
  • Work flow systems

Our QA staff participates directly in client and FDA inspections, in order to heighten their knowledge of industry trends, inspection strategies, and current FDA guidelines. QA staff also attends external formal training classes in current regulatory topics to further broaden their knowledge base.