At Myers QC, we know every organization has unique challenges as they work to comply with regulations.  As a result, we do not have a “one-size-fits-all” approach to our services.  Instead, we work with you to custom tailor the correct solution for you specific needs.  Our services include:

Comprehensive Audits:

• Quality Assurance Audits
• Vendor Qualification/Assessments
• Gap Analysis
• Compliance Audits

Short Term Projects to Longer Term Quality Support:

• Designing, Developing and Managing Quality Systems
• Training in GCP, GLP, Writing Effective SOPs, Deviation Management/Root Cause Analysis and other Topics
• Project Management
• SOP Development and Writing
• Evaluation of Corrective Actions

Regulatory Assistance:

• FDA Inspection Readiness for Sponsors/Manufacturers and Clinical Investigators
• Responses for FDA-483s and/or Warning Letters