Regulatory operations

Regulatory operations

To make sure that your application conforms with all other requirements beside the scientific requirements, we support regulatory operations and provide publishing services.

Regulatory operations:

  • (Bio)Pharmaceuticals
    • Prepare documents to be added in Module 1 of the CTD such as the cover letter, application form, tracking table/life cycle management table, review guide etc.
    • Arrange legalization of hard copy signed documents by embassy and/or apostille
    • Assess fees to be paid to health authorities and advise on the fee payment processes
    • Submit dossiers to health authorities through the applicable web portals
    • Maintain registration databases
  • Medical Devices
    • Project management including submission/certification planning
    • Quality system operations
    • Medical device technical documentation management, e.g. help to setup and maintain a database with version-managed documentation such that all product compliance information is available for submission/certification and recertification audits
    • Submit conformity assessment request with EU Notified Bodies and agency notifications
    • Unique Device Identification (UDI) data management

Publishing services:

  • (Bio)Pharmaceuticals
    • Prepare company CTD template documents (MS Word)
    • Advise your team how to use the company template documents to author eCTD compliant documents
    • Convert MS word documents to eCTD compliant PDF documents
    • Publish dossiers in eCTD and NEES format
  • Medical DevicesPrepare
    • Technical Documentation templates (MS Word and Excel) 
    • Advise on the documentation templates to be used for the applicable reviewing agency and route of conformity for your product(s)
    • Submission archiving