We help life sciences organizations build and maintain strong, compliant quality systems across the product lifecycle.
Develop and deploy compliant QMS frameworks that support product safety, efficacy, and consistency.
Ensure readiness with qualified instruments, validated software, and documented procedures aligned with GLP, GMP, and 21 CFR Part 11.
Maintain reliable operations with consistent equipment and system performance, supported by robust,
audit-ready documentation.
Present organized, defensible quality records to simplify inspections and reduce regulatory risk.
A robust QMS is more than a requirement—it’s essential for product safety, consistency, and compliance. Pinnaql works with pharmaceutical and medical device companies to develop frameworks that align with ISO 13485, cGMP, GLP, and FDA expectations—reducing compliance risk, improving audit outcomes, and strengthening quality across the product lifecycle.
Maintaining compliance in life sciences is complex, with evolving regulations and high stakes. Pinnaql equips your team with proactive compliance strategies and hands-on support during regulatory challenges—strengthening inspection outcomes, preventing future issues, and embedding continuous compliance into your operations.
Modern quality systems demand digital infrastructure that drives compliance, efficiency, and insight. Pinnaql helps organizations implement eQMS platforms that are compliant, practical, and seamlessly integrated across operations—improving traceability, reducing manual work, and ensuring your compliance infrastructure scales with growth.
When regulatory issues escalate into legal matters, expert insight is critical. Pinnaql provides experienced consultants to serve as expert witnesses and technical advisors. Our experts bring deep industry knowledge and regulatory expertise, ensuring that legal teams and organizations are equipped to handle FDA-related matters effectively. With the backing of experienced engineers and scientists, we offer unique insights that bridge the gap between regulatory compliance and technical feasibility.
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