Keshu Nso - Senior Director
Keshu Nso is a quality and regulatory affairs professional. She is an expert in providing strategic regulatory guidance and managing regulatory communications directed toward regulatory submissions for the biotech, pharmaceutical, and medical device industries. Keshu is a subject matter exert in quality management systems including premarket, production and postmarket. She has extensive knowledge of medical device classification, regulation, and registration for the US, the EU, Japan, and Canada including FDA regulatory submissions experience in BLAs, CMC INDs, NDAs/ANDAs, 510(k)s, Denovos and PMAs. She is trained/certified auditor in ISO 13485 QMS, EU MDR, and MDSAP and has experience in multiple other audits including of 21 CFR, ISO 14971, and QMS. Keshu has successfully supported regulatory affairs’ life-cycle management activities and provided regulatory guidance to all aspects of a business’ operations.
