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||Market access||Post-market support|
|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||Regulatory submissions|
|Acting as applicant and MAH||Writing and submission of Swiss value dossiers||Acting as Swiss Quality, PV and Compliance Responsible Persons|
|MAA filing and liaison with Swissmedic||Liaison with HTA and reimbursement bodies||Auditing distributors on clients’ behalf|