About
Medical Device, Pharmaceutical, Biologics, and IVD Regulatory and Quality Compliance consulting (GCP, GLP, GMP) We have an expertise in CAPA/Investigations, Remediation, Supplier Management, Training and Auditing. Due Diligence, inspection preparation, FDA mock audits, 13485/820 QMSR transitions. Risk-based thinking and QMS implementations. Our Philosophy: Progressive Improvement BEATS Postponed Perfection. Our methodology for being a change agent is based on this belief. The Key: Enrolling and engaging people in the change process and getting them to believe that there is a way to attain a high level of operational excellence...step by step, using good project management skills and leadership tools.
Technologies
OutlookWordPress.orgNginxMobile FriendlyGoogle Tag Manager
Keywords
auditstrainingtechnical writingmedical devicebiologicscapafdasupplier controlssupplier auditseu mdriso 13485investigationpharmaceuticalgap analysismedical equipment manufacturingattrition reduction in qa/qc teamsremediationgmpregulatory complianceproject managementbiologics compliancechange managementivd regulatory supportcapa investigationslab root cause analysissupplier managementinvestigation hands-on trainingconsultinginvestigation traininginvestigation report writing
Company Information
- Employees3
- Founded2023
Location
Minneapolis, Minnesota, United States
