Turn regulatory challenges into market opportunities with ARx’s pharma-grade QA systems.
ARx’s quality systems are designed to exceed regulatory expectations, ensuring every product meets the highest safety, efficacy, and consistency standards. Our teams implement rigorous testing protocols, in-line monitoring, and real-time data analytics to maintain compliance with 21 CFR Parts 210 & 211 and CFR 820.
We collaborate closely with partners to build customized QC strategies, including impurity profiling, dissolution testing, and stability studies, ensuring products keep their intended performance. By aligning quality management with commercial objectives, we mitigate risks, streamline approvals, and build trust with regulators and patients.
Regulatory Certainty: Nine successful FDA inspections and four “no observation” DEA inspections since 2006.
Supply Chain Protection: Selected materials meet pharmacokinetic needs, quality standards, and IP strategies.
True Partnership: Cross-functional integration through ASQ-certified GMP professionals aligned with your development goals.
Perpetual Advancement: Systematic process refinements based on six decades of expertise in thin film and adhesive polymer science.
Global Market Access: Comprehensive documentation supporting worldwide regulatory filings, backed by thorough monitoring programs.
Our quality support services ensure your products maintain the highest standards from development through commercial production.
ARx provides comprehensive quality management that integrates with your systems, including supplier quality, quality assurance, and quality control with finished product testing & release.
Interested in how novel drug delivery systems compare to traditional methods?
Explore their unique advantages and identify the best fit for your formulation needs.
At ARx, we transform quality requirements from obstacles into strategic advantages for our pharmaceutical partners. Our proven systems deliver the compliance certainty you need—accelerating your path to market while ensuring patient safety and therapeutic effectiveness.
