Engineering compliance. Delivering confidence.

Strategic manufacturing operations start with disciplined planning and technical oversight. Pinnaql leads capital and production initiatives across life sciences facilities—ensuring readiness, regulatory alignment, and smooth execution from kickoff to qualification.

Manufacturing systems must deliver more than output—they must sustain safety, quality, and adaptability. Pinnaql provides full-spectrum engineering support, helping you manage assets and processes across their lifecycle with regulatory precision and operational foresight.

Pinnaql delivers end-to-end Commissioning, Qualification, and Validation (CQV) services to ensure your facilities, equipment, and processes meet cGMP expectations—efficiently, thoroughly, and in full alignment with FDA, GAMP, and ICH standards.

Your digital systems are central to manufacturing—and under constant regulatory scrutiny. Pinnaql ensures your MES, SCADA, BAS, and data platforms meet FDA expectations for data integrity, audit trails, and system validation.

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.