Mishler Consulting specializes in Quality & IT business consulting, empowering small to medium-sized life sciences organizations to achieve compliance and operational efficiency. Smaller life sciences organizations have historically been underserved in the Quality & IT space, and I'm here to make an impact.
I understand the challenges of getting a Quality Management System established, IT program/project management, implementing electronic GxP systems, sitting across from an FDA inspector to defend your Quality System, all while performing your day-to-day work. I’ve lived these same challenges and am here to partner with you to solve them.
Core Services:
• IT Program/Project Management
• GxP System Implementation, Administration, & Release Management
• GxP System Assessment & Optimization
• Training & Organizational Change Management (OCM)
• GxP Vendor Qualification Audits & FDA Inspection Readiness
• Business Process Design & Standardization
Extensive Expertise in:
• Veeva Vault and other electronic GxP systems such as MasterControl, ZenQMS, TrackWise
• Regulated life sciences space including, medical devices, combination products, pharmaceuticals, biotech, and CDMOs
• Document Management, Records Archival, Change Control, Deviations, Nonconformances, CAPA, Audits & Inspections, Supplier Quality Management, application of Risk-Based approach, Training, Batch Release, and Validation
Company Details
- Employees
- 1
- Founded
- -
- Address
- Portland, Oregon, Us
- Industry
- Business Consulting And Services
- NAICS
-
Management, Scientific, and Technical Consulting ServicesManagement Consulting ServicesOther Scientific and Technical Consulting ServicesOther Management Consulting Services
- Keywords
- GxP System Implementation, Business Process Standardization, Project Management, Quality Consulting, IT Consulting, FDA Inspection Readiness, Life sciences, Document Management, Business Consulting, Quality Management System, Veeva Vault, CAPA, Deviation, Training, Organizational Change Management (OCM), Batch / Lot Release, ISO 13485, ICH Q10, GxP Vendor Audits, Program Management, GxP Vendor Qualification, Audits.
- HQ
- Portland, Oregon
Mishler Consulting Questions
Mishler Consulting's LinkedIn profile is https://www.linkedin.com/company/mishler-consulting
Mishler Consulting has
1 employees.
View email and phone details for 1
employees at Mishler Consulting.
Mishler Consulting's industry is
Business Consulting and Services
Mishler Consulting's top competitors are
Nuvera Life Science Consulting,
Litify,
Stryker,
Bachem,
Cascade Change Consultants,
Veeva Systems,
Mittal Consulting,
Qval Consulting,
Nnit,
Fraser Dove International.
Mishler Consulting's categories are Business Consulting and Services
Mishler Consulting's founding year is 2024
