A quality system is the very core of how a pharmaceutical/biotech company can maintain or enhance quality in every facet of their processes, stay aligned to the expectations of key internal/external stakeholders (e.g., regulatory agencies, patients), and support the company’s commitment to delivering world-class medical treatments.

Our clients are proactive in how they define, execute, and communicate their value proposition and offerings.

Quality system challenges require more innovative and flexible solutions. We know that you are facing:

  • Friendly Consultant ChicagoIncreasing regulatory pressures and expectations coupled with more aggressive inspection activity,
  • An explosion of data/documentation, and
  • Highly complex, global clinical trials

 

You can rely on our professionals to help you navigate these hurdles. We know the pitfalls and can help you be successful without having to figure it out for yourself.

Tell us about your Quality needs

Improve your Quality Assurance Program

Our expert consultants bring focused methodology and deep Life Sciences expertise so that you can achieve your goals. Let us partner with you for:

  • Quality Assurance Strategy Development & Capability Assessment
  • Quality Planning/Execution
  • Quality Documentation Development/Approval
  • Documentation Practices Excellence
  • CAPA Process Design/Execution
  • Change Management Process Design/Execution
  • Vendor/CRO Oversight Process Design/Execution
  • Quality Management System Audits
  • GxP Audits

Become a Leader in Quality Assurance / Quality Systems

Our seasoned professionals have successfully delivered:

  • Assessment and revamp of a QA Strategy and Capability Focus Areas
  • Cross-functional R&D QA Center of Excellence
  • Cross-functional CAPA Process Optimization, Supporting Training & Job Aids, and Functional CAPA Process Optimization/Supporting Materials
  • Revision, retirement, or creation of Quality Documentation suite of policies, processes, and procedures

Let’s Get to Work