Regulatory Affairs

The multi-disciplinary approach at SFL enables us to provide state-of-the-art, innovative and customized regulatory solutions for our clients. These range from regulatory strategy and advice on the development of healthcare products, to hands-on operational support during product registration and post-marketing activities. Support to meet regulatory compliance facilitates entry to market and helps minimize the risk of failure thereby reducing development costs.

Our highly educated regulatory affairs professionals have long-standing experience in many therapeutic areas (e.g. oncology, cardiovascular, neuroscience, infectious diseases, immunology) and product classes (e.g. drugs, medical devices, IVDs, combination products, borderline products, ATMPs). The team’s regulatory experience covers the EU, Switzerland, US markets as well as other global regions such as APAC, MENA and LATAM.

 

Pre-registration

Registration of medicinal products and CE-marking of medical devices and IVDs

Post-marketing activities

Full Support for the Swiss Market

Publishing