Stuck in your projects?
Have you thought about regulix LTD?

Our service

The following are only a few of the services we offer to help address your needs:

  • Setting up regulatory strategies
  • Project management or assistance for development and facility projects
  • Preparation of documentation for marketing authorisation (Switzerland [CH], EU, USA, Canada etc.) including eCTD-compilation
  • Preparation of clinical trial applications (such as IMPDs, INDs)
  • Preparation of documentation for post-authorisation filings such as variations,  renewals, labelling changes and complete review letters
  • Preparation and filing of reimbursement applications for Switzerland
  • Any kind of interaction with regulatory agencies
  • Experience in search for appropriate current medicinal law and guidelines
  • Translation services for medical and technical documentation (English, German and French)
  • Technical support in the field of Quality Management
  • Serving as “Qualified Person” (Fachtechnische Leitung) for the Swiss market
  • Safety Data Management