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