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Regulatory Affairs Operations & QA

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.

RA Operations & QARegulatory Affairs Operations

  • 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

Having worked with the eCTD format in house for the past 10 years we have strong focus on Global eCTD submission and Document Management.

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.