Gateway to regulatory success and market entry in Switzerland
Our expertise facilitates successful and speedy registration and market access for medicinal products in Switzerland.
SFL has a full quality management system and holds a Swissmedic establishment license, a pre-requisite for submitting marketing authorization applications (MAA) in Switzerland. Therefore, on behalf of our clients, who do not have a Swiss subsidiary or do not have the necessary Swissmedic licenses, we act as applicant of MAA in Switzerland and bring your innovative products onto the Swiss market in compliance with Swiss law.
Regulatory strategy, ODD, CTA
Market access strategy for medicinal products
Full lifecycle management including RA, PV and QA support
Establishing quality management systems
Support with early access schemes
Acting as applicant and MAH
Writing and submission of Swiss value dossiers
Acting as Swiss Quality, PV and Compliance Responsible Persons