We are flexible and scale to fit the needs of your organization. We offer the following Quality and Regulatory expertise:

Quality Management System (QMS)

• System Validation and Change Control
• Change Management Oversight
• Policies, Procedures, Training, Qualifications, Validations
• Compliance and Quality Data Review

Auditing and Deviation Management

• Auditing Preparedness
• Non-conforming Product Evaluation
• Root Cause Analysis
• Process Management and Improvement

Regulatory Requirements

• Licensing (Facility or Product)
• Regulations, Standards & GXP
• Privacy & HIPAA
• Safety Laws and Regulations (OSHA)
• Updated FDA 3PL Licensing Standards

Relationship Management

• Hosting External Inspections
• Quality Agreements
• Supplier Qualification