Nova eQMS is founded and led by Pooja Kannam, a Quality and Regulatory Affairs executive with extensive experience across medical devices, pharmaceuticals, 503B outsourcing facilities, and chemical manufacturing.
Her expertise spans global regulatory frameworks including ISO 13485, FDA 21 CFR Part 820, and 21 CFR Parts 210 and 211 for pharmaceutical Good Manufacturing Practices, along with regulatory requirements for 503B outsourcing facilities.
Pooja has led the development, implementation, and remediation of Quality Management Systems across organizations ranging from startups to complex manufacturing environments. Her work includes regulatory strategy, 510(k) submissions, GMP system implementation, supplier quality management, process validation, and inspection readiness for FDA and ISO audits.
She has worked extensively with contract manufacturers, outsourcing facilities, and global supply chains, addressing critical challenges such as data integrity, contamination control, and compliance in both sterile and non-sterile environments.
Nova eQMS was built directly from this experiencebto create a system that is not only compliant, but practical, scalable, and aligned with real-world operations.
