The Regulatory Affairs Operations & QA Team consists of experienced specialists; over the past four years we have run more than 100 EU MA procedures. The team is headed by Connie Thestrup.
- provides guidance and regulatory strategies
- prepares and runs all types of marketing authorisation procedures, e.g. handling deficiency letters during procedure/variation, finalising the procedure/variation, and the national phase after the initial MA procedure is complete
- is responsible for national procedures, MRPs, DCPs and CPs,
- provides support and management for the maintenance of readily approved products
- covers variations, renewals, MA transfers, and withdrawals
The team also maintain the Quality Management System for IWA Consulting to comply with the Quality Standards of DS/EN ISO 9001.
For more information about RA Operations, QA, the team, and our services, please contact Connie Thestrup.