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.

QLeaR Advisors

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QLeaR Advisors

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