Switzerland is a premium, highly innovative market in Europe with world-leading pharmaceutical and medical technology sectors, offering exceptional opportunities for global manufacturers.
Swissmedic, the Swiss Agency for Therapeutic Products, is the independent national authority responsible for authorizing and supervising therapeutic products (medicines, medical devices, in vitro diagnostics, and biologics) in Switzerland. Although not an EU Member State, Switzerland maintains a high degree of regulatory alignment with the EU through bilateral agreements and mutual recognition (including for GMP and device conformity). Swissmedic handles national authorizations, accepts certain EU centralized/DCP/MRP procedures with Swiss-specific requirements, and manages clinical trials, pharmacovigilance, vigilance, and local compliance (including Swiss language labelling). MedWisdom LifeScience provides expert regulatory affairs support to help foreign manufacturers navigate Swissmedic’s rigorous yet predictable framework, prepare compliant submissions, secure efficient approvals, and achieve sustained compliance in this high-value and strategically important market.
Get Switzerland Compliance Support
Expert CTD/eCTD dossier compilation, Module 1 Swiss-specific adaptation, scientific/technical review, and quality assurance for Swissmedic submissions.
Complete management of national Swiss authorizations, recognition of EU procedures, variations, and submissions via Swissmedic portal, including query handling.
Preparation and submission of Clinical Trial Applications to Swissmedic, ethics committee (Swissethics) coordination, and regulatory support for trials in Switzerland.
Swiss QPPV/local contact person services, PSUR/PBRER submissions to Swissmedic, adverse event reporting, signal detection, and RMP maintenance.
Support for Swiss conformity assessment (leveraging EU MDR CE marking via MRA), Swissmedic notification/registration, vigilance reporting, and compliance in Switzerland.
PMS/PMSR implementation, trend reporting, FSCA notifications, vigilance compliance, and ongoing monitoring per Swissmedic and EU-aligned requirements.
Swiss labelling review (German/French/Italian requirements), Swissmedic-specific elements, mock-ups, readability testing, and approval support.
Support for post-approval changes, renewals, line extensions, and full lifecycle compliance with Swissmedic and EU-aligned standards.
Strategic consulting, optimal pathway selection (national/recognition of EU procedures), Swissmedic scientific advice preparation, and up-to-date Swiss regulatory intelligence.
Partner with Medwisdom for expert, efficient, and fully compliant regulatory support in Switzerland — from Swissmedic submissions and device conformity to pharmacovigilance, Swiss labelling, and sustained market success.
Contact Our Switzerland Regulatory Experts