Turning your challenges into solutions

At QSN, we partner with drug, medical device, biologics, and combination products manufacturers to deliver highly-skilled, specialized-knowledge resources for mission-critical projects including product launch, regulatory compliance, large-scale change, and process improvement. We are known for our straightforward approach to solving your most complex business challenges, providing on-demand strategic support and tactical project management expertise to assist you during an interim period when staffing is low or as an extension of your current team.

Case Studies

• Large-Scale Change for Drug Manufacturer – Case Study
• Process Improvement for Drug/Biologics Manufacturer – Case Study
• Product Launch for Biologics Manufacturer – Case Study
• Regulatory Compliance for Medical Device Manufacturer – Case Study

Product Launch

• Design Control Activities
  • Design History Files
  • Design Verification/Design Validation
  • Risk Management

• Process Control Activities
  • Process Validations
  • Process Control Plans
  • Inspection Methods/Test Methods

• Product and Process Development Expertise
  • Research & Development
  • Quality Engineering
  • Manufacturing Engineering

• Methods and Tools
  • DMADV Methods
  • DFSS Methods
  • Process Capability

• Training
  • Design Control
  • Risk Analysis
  • Six Sigma Methods for Design 

Large-Scale Change

• Change Management Activities
  • Product/Technology Transfers
  • Product/Process/Supplier Changes
  • Expansions/Decommissioning/Delisting

• Project Management Expertise
  • Change Management
  • Project Leadership/Management
  • Project Facilitation/Coordination

• Methods and Tools
  • Project Charters
  • Dashboards/Project Plans
  • Stakeholder Analysis/Communication Plans

• Training
  • Project Management
  • Project Planning
  • Team Development

Regulatory Compliance

• Regulatory Affairs Activities
  • Device Listings/Establishment Registrations
  • Regulatory Submittals
  • Medical Device/Adverse Event Reporting/Recalls

• Quality System Activities
  • Quality System Development
  • Quality System Support
  • Auditing

• Regulatory Affairs, Quality Systems, & Compliance Expertise
  • Regulatory Management
  • Quality Management
  • Compliance Management

• Training
  • FDA 21 CFR Parts 210/211
  • FDA 21 CFR Part 820
  • ISO 9000/13485/14971

Process Improvement

• Process Improvement Activities
  • Cost Savings
  • Customer Service
  • Cycle Time Reduction

• Process Improvement Expertise
  • Quality Improvement
  • Performance Improvement
  • Six Sigma/Lean Manufacturing

• Methods and Tools
  • Root Cause Analysis
  • DMAIC Methods (Define, Measure, Analyze, Improve, and Control)
  • Data/Statistical Analysis 

• Training
  • Process Improvement Training
  • Six Sigma Training
  • Lean Manufacturing Training