Expert regulatory guidance for establishing your Swiss Pharmaceutical Operations
Expanding into Switzerland’s highly regulated pharmaceutical market requires more than ambition—it demands precision, compliance and local expertise. Whether you’re planning to trading abroad, import, release, or distribute pharmaceutical products, out from your Swiss legal entity, obtaining the right Establishment License is the essential first step—and we’re here to guide you through it.
We support pharmaceutical companies—especially small to medium-sized enterprises—through every stage of the Swissmedic licensing journey, with tailored, end-to-end services:
Strategic Licensing Planning
- Guidance on the type of Swissmedic Establishment License required
- Step-by-step compliance roadmap
- Timelines, document planning, and risk mitigation
Appointing the FvP (Responsible Person)
- We provide or help designate a qualified Fachtechnisch verantwortliche Person (FvP)
- The FvP oversees inspections, release processes, and serves as your compliance liaison with Swissmedic
Quality Management System Development
- Gap analysis of your current procedures
- Drafting or updating SOPs and documentation
- Full alignment with Swissmedic's QMS expectations
Inspection Preparation & License Submission
- Preparing all paperwork for Swissmedic site inspection
- Coordinating with authorities and scheduling inspection dates
- Supporting final submission and response to authority feedback
Securing a Swissmedic Establishment License is no easy feat. Complex regulations, quality system expectations, and inspection requirements can be overwhelming—especially for small to medium-sized enterprises.
That’s where we come in.
Why the Establishment License Matters?
The Swissmedic Establishment License is not only required for importation and release of products—
it is also a mandatory prerequisite for submitting a Marketing Authorization (MA) application in Switzerland.
Without it, you cannot legally commercialize pharmaceutical products in the country.
We ensure you meet this requirement efficiently and strategically, so your path to full market access is clear.
“To succeed with Swissmedic licensing, companies must tailor their strategy to the specific license type.
A robust Quality Management System is essential—not optional.
Expert guidance can mean the difference between delay and approval.”
Company Owner Switzerland
