Deepthi Suri

Manager - Regulatory Compliance Specialist @NeilMed Pharmaceuticals

Bengaluru, IN

Co-ordinate and submit licenses and authorizations for the maintenance of existing products, international registrations and dossiers, updates to technical documentation leading a team of 4 Regulatory specialists. Working experience on registration of Drugs and Medical devices on CDER and CDRH portals, ACTD filing on Health and Science Authority (HSA), Singapore, and NHP filing on epost Connect, Medical Device product registrations with Health Canada; Product Registration Renewals, response to queries to get the Approvals meeting the timelines. Provide Regulatory Affairs support during external and internal audits. Representing RA in Notified Body Audits (Surveillance, MDSAP, ISO 13485)