Our Services

The following are just 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, 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 authorities
• Research into applicable laws and guidelines
• Translation services for medical and technical documentation (English, German and French)
• Technical support in the field of quality management
• Acting as Responsible Person (QP / FvP) for the Swiss market
• Safety data management

All documents can be provided in English, German or French.

Our Experience

We have in-depth industry experience in both national and international regulatory environments, specifically in the registration of sterile preparations, biological products, vaccines, OTC products and registration of production plants. It is one of our strengths to adapt to our customers’ needs.

Our professional experience, which spans more than two decades, comes from working in the challenging regulatory field dealing with Swiss, European and US health authorities. This enables us to meet your needs.

Our Strengths

Regulix  welcomes new and challenging assignments, keeps its sense of humour (sometimes dark) in crisis situations and takes a creative approach. 

We have strong communication and motivational skills.