Nagalakshmi Kannuchamy
Regulatory and Quality Assurance Lead @Future Fields
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WORK HISTORY
Regulatory and Quality Assurance Lead @Future Fields
EDUCATION
Central Institute of Fisheries Education
Doctor of Philosophy (Ph.D.)
Central Institute of Fisheries Education
Master's degree, Fisheries Science, Post-Harvest Technology
Fisheries College and Research Institute, Thoothukudi
Bachelor's degree of Sciences (B.F.Sc), Fisheries Science
University of Alberta
Master of Science - MSc, Food Science and Technology
ABOUT NAGALAKSHMI KANNUCHAMY
Regulatory Affairs professional with 15+ years of experience in Pharma, biotech, food, and natural health products, specializing in CMC regulatory strategy, CTD Module 3 authoring, and global regulatory submissions including IND and CTA filings. Experience in submissions like New Substances Notification (NSN), Cosmetic notifications, NPN etc. I have deep hands-on experience supporting end-to-end regulatory lifecycle activities including dossier preparation, gap assessment, regulatory strategy development, and compliance with FDA, Health Canada, and ICH requirements. My expertise spans Module 3 (Quality/CMC), technical documentation, product development support, and regulatory intelligence for complex biologics, nutraceuticals, and food-related health products.I have worked closely with cross-functional teams across R&D, QA/QC, manufacturing, and clinical/regulatory functions to ensure submission-ready documentation aligned with global expectations.Core strengths include:CTD Module 3 (Quality / CMC) authoring & reviewIND / CTA regulatory submissions, New Substances (NSN), NPN and CI etc. Regulatory strategy for biotech, food & natural health productsHealth Canada & FDA complianceTechnical writing, gap analysis & dossier lifecycle managementCross-functional regulatory leadership in global environments
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