eSUBMISSIONS

Our eSolutions services include consulting services in all areas of Regulatory Operations, e.g. transition to electronic submission, compliance with EU eSubmission Roadmap, submission process optimisation, implementation of efficient Regulatory Information Management (RIM), compliance with XEVMPD and IDMP requirements as well as other innovative topics in the framework of Regulatory Operations.

Inpharmatis is the named partner of Extedo GmbH in the Baltics and CIS Region.

  • Full eSubmissions Services for pharmaceutical and medical device companies
    • Europe (CP, MRP, DCP, national and maintenance)
    • FDA
    • Health Canada
    • Swiss Medic
    • Others
  • eCTD Support for Active Substance Master Files
  • Document templates
  • Implmentation of eSubmission tools:
    • eCTDManager
    • PcVManager
    • Document Management Systems