A well-designed and stage-appropriate Quality Management System (QMS) is essential for development and commercialization. We understand the complexities of managing quality and compliance in the biopharma industry. Our Quality expertise helps companies of all sizes establish and maintain appropriate controls, manage ongoing changes, and address operational events to advance treatments into the clinic and out to market.
The support from Converge Consulting’s team exceeded our expectations! They brought flexibility and subject matter expertise to areas critical to our launch, including Quality Assurance and technical writing.
– Senior Director, Emerging Biopharma Company
How do you ensure a reliable and scalable Quality System?
- Stage-Appropriate QMS Design
- Quality Assurance & Compliance Strategies
- Quality Organization Design & Functional Strategies
- Interim Quality Leadership
- cGMP Quality Risk Strategy & Assessments
- PAI Readiness
- Business Process Design & Optimization
- QA Operations: Batch Record Reviews, CAPAs, Deviations, Investigations & Audits
- QC Partner Selections
- Vendor Qualification, Selection & Management Programs
- Quality Control and Analytical Methods Development, Validation & Transfer
- Process & Equipment Validation
- QMS Software Strategies & Selections
- Document Management Strategies & System Selection
- Risk Assessments/FMEA
- Stability Studies
- Quality Document Authoring (SOPs, Work Instructions, Forms, Policies)
