We are flexible and scale to fit

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