Whether you are building a new facility from the ground up or responding to critical regulatory feedback, ARIREX is your partner in high-stakes situations. We support you at every critical turning point, turning compliance challenges into operational milestones.
For start-ups, we design scalable quality systems that grow with you. For companies facing enforcement actions (Warning Letters, 483s), we provide the expertise and manpower to remediate issues quickly and restore regulatory trust.
Critical Support
Our team thrives in complex environments, delivering clear strategies and hands-on execution when it matters most.
- Quality Management System Design for Startups.
- Facility Commissioning & Qualification Support.
- FDA Warning Letter/483 Response & Remediation.
- Consent Decree Support & Independent Expert Review.
- Data Integrity Remediation Programs.
Speed & Sustainability
We balance the need for speed with the necessity of sustainable, compliant solutions.
- Faster Time to Market: Get your facility up and running right the first time.
- Regulatory Confidence: Demonstrate a robust response to regulatory findings.
- Sustainable Compliance: Build systems that prevent recurrence of issues.