OUR MISSION

TO IMPROVE YOUR BUSINESS' PERFORMANCE AND PROVIDE A SUCCESSFUL CLINICAL RESEARCH DEVELOPMENT PLAN AND STRATEGY.

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NO OBLIGATION CONSULTATION   +1.724.272.1245

Alethea
David Link, MBA

Years of experience: 30+
Chief Quality Officer | Executive Management Consultant


Innovative and transformative leader with 30 years of progressive accomplishments in Quality Engineering, Quality Assurance, and Quality Management with market leading technology and medical device manufacturers, a track record of assuring customer quality satisfaction and improving profitability by identifying critical priorities, marshalling commitment, and managing cross-functional teams to successfully execute, and proven ability to deliver results by solving complex problems, driving change, and fostering and enabling quality culture for learning and improvement.

• Quality and Regulatory Strategy • Customer Quality Relationship Management  • Manufacturing/Acceptance Quality
• Regulated QMS: ISO 13485/9001/QSR • Corrective and Preventive Action Champion • Supplier Quality /APQP/PPAP                              
• QMS Development and Management • Cost of Quality Decision Support • QMS Compliance and Process Auditing
• Mentoring and Coaching • Post-Market Surveillance and Reporting • Lean Process Reformation/Optimization
• Team Development and Leadership • Regulatory Interface and Engagement • Statistical Decision Analysis and Support         
• Project and Program Management • Product Quality Lifecycle/Risk Management • Lean Six Sigma Black Belt

ALETHEA WIELAND

Years of experience: 25+
President & Founder | Executive Management Consultant


• Board of Directors • Foreign direct investment relationship building ​• US transfer pricing regulations • Arms' length agreements 
• US FDA Regulatory Strategy and Submissions ​​• IND Regulatory Agent • International Regulatory Agencies and Notified Bodies 
• 20+ years of corporate compliance in life sciences and federally-funded programs • 20+ years of international clinical research
  operations, trial design and execution, QA, inspection-readiness, and CRO selection/management • Trial and publication governance,
  business development, and board interactions • Strategic planning, risk management, change management, continuous quality
  improvement implementation, and training • Fiscal discipline and pragmatic forecasting that reduces the squandering of resources or
  unexpected spend • Lifetime of true grit, creativity, innovation, collaboration, accountability, flexibility, and win/lose early mindset

• 2017 Governor Tom Wolf Recognition in PA Life Sciences • 2017 Women in Bio P.O.W.E.R. Award • 2017 Pittsburgh City Council
​   Recognition in Life Sciences