Pinnaql delivers integrated quality operations and compliance services across pharmaceutical, biotech, and medical device sectors. We combine technical engineers, lab scientists, and QA experts to develop systems that are technically sound, practical to execute, and built for global regulatory expectations.
This collaborative team ensures your quality operations support product integrity, data reliability, and successful inspections—without slowing down your operations.
We’ve structured scalable systems to help reduce risk, support data integrity, and streamline execution across your operations.
Systems are grounded in how your operations actually work—eliminating recurring issues and improving inspection outcomes.
Engineers, scientists, and QA collaborate to design compliant, scalable, and traceable change control frameworks.
Validation is connected to process performance, not just paperwork—applying Lean and Six Sigma to reduce risk and increase efficiency.
We apply proactive frameworks (FMEA, hazard analysis) to ensure your systems are defensible and aligned with FDA, EMA, and ISO standards.
In GxP environments, every deviation, corrective action, and SOP must reflect how your operations actually function—not just what looks good on paper. Pinnaql delivers real-world, risk-based systems designed for clarity, traceability, and audit readiness—reducing repeat issues, improving audit outcomes, and embedding sustainable compliance practices across your teams.
In regulated lab and manufacturing environments, change is constant—but unmanaged change can create serious compliance risks. Pinnaql designs and implements risk-based change control programs that are compliant, traceable, and operationally practical—ensuring business continuity and audit readiness from proposal to closure.
Quality shouldn’t stop at compliance—it should drive operational performance. Pinnaql applies quality engineering principles to optimize processes, reduce variability, and improve throughput across labs and manufacturing, all while maintaining full regulatory alignment.
Pinnaql delivers end-to-end CQV services to help you launch, scale, or remediate with confidence. We ensure your facilities, utilities, equipment, and processes meet cGMP requirements and operate with consistency, quality, and compliance from day one.
Digital systems are essential—and increasingly scrutinized. Pinnaql helps life sciences organizations validate manufacturing and lab software to meet 21 CFR Part 11, GAMP 5, and global data integrity standards. We bridge the gap between IT and OT to ensure reliable, compliant performance.
101 Lindenwood Drive, Suite 225 Malvern, PA. 19355
9800 Crosspoint Blvd, Suite 200, Indianapolis, IN. 46256