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

Product Launch

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

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

  • Research & Development
  • Quality Engineering
  • Manufacturing Engineering

  • DMADV Methods
  • DFSS Methods
  • Process Capability

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

Large-Scale Change

  • Product/Technology Transfers
  • Product/Process/Supplier Changes
  • Expansions/Decommissioning/Delisting

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

  • Project Charters
  • Dashboards/Project Plans
  • Stakeholder Analysis/Communication Plans

  • Project Management
  • Project Planning
  • Team Development

Regulatory Compliance

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

  • Quality System Development
  • Quality System Support
  • Auditing

  • Regulatory Management
  • Quality Management
  • Compliance Management

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

Process Improvement

  • Cost Savings
  • Customer Service
  • Cycle Time Reduction

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

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

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

Partnering for Excellence in Life Sciences Consulting

At Quality Solutions Now (QSN), we specialize in delivering tailored consulting services to the life sciences industry, encompassing drug, medical device, biologics, and combination product manufacturers. Our expertise spans product launches, regulatory compliance, large-scale organizational changes, and process improvements. With a team of seasoned professionals, we provide strategic support and tactical project management to address your most pressing challenges.

Ready to Elevate Your Operations?

Discover how QSN can support your organization’s growth and compliance objectives. Contact us today to learn more about our services and how we can collaborate to achieve your goals.