Be Prepared. Be Responsive. Stay Compliant.
Whether you’re facing your first FDA inspection or audit, or dealing with required remediation planning, QUARA can lift the stress and burden of preparation and follow-up. You focus on innovation—your expertise. We’ll bring best practices to your business and manage device regulatory affairs and quality assurance activities.
Leverage the expertise of our team.
We work with a full range of healthcare, life sciences and medical device companies at all stages in the business life cycle. QUARA manages all aspects of the FDA inspection process, from inspection readiness to managing FDA inspections and audits, post-audit observations, authoring corrective actions and other required remediation planning.
Access tailored FDA compliance services.
Outsource as much—or as little—of the FDA compliance, inspection and preparation process that you choose.
- Quality System Assessment & Development
- FDA Inspection Readiness
- FDA QSIT (Quality System Inspection Technique)
- Managing FDA Inspections
- FDA Inspection Follow-Up
- Warning Letter Responses
- Post Market Activities
- CAPA
- Remediation Planning
- Document Control
- Production and Process Controls
- Process Validation