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Strategic Regulatory Partner for Success in Switzerland

Greetings from

Pharma Wizard Switzerland Regulatory Services

Pharma Wizard: your trusted partner for regulatory affairs and compliance in Switzerland. Complete pharmaceutical services from registration to approval.

With a robust blend of public and private healthcare systems, Switzerland is a promising destination for foreign medical device and pharmaceutical manufacturers. To maintain the high standards of imported products, SWISSMEDIC – the Swiss agency for therapeutic products – governs the regulatory and legal frameworks for medicinal products and medical devices. Organizations must meet Swiss requirements for product safety, yet the procedural complexities can pose challenges to manufacturers’ market entry strategies.

Pharma Wizard, a dedicated global Regulatory solutions provider, supports manufacturers in staying aligned with Swiss market updates and navigating the complete market authorization journey.

Industries We Serve in Switzerland

Medical Devices Regulatory Support in Switzerland

Switzerland holds a leading position in medical technology innovation. Following its departure from the EU’s single market, it established its own regulatory framework – the Medical Device Ordinance (MedDO) and In Vitro Diagnostic Devices Ordinance (IVDO). While initially modeled after EU Directives, both ordinances have since been updated to align with the European Union Medical Devices Regulation (EU MDR) 2017/745 and In Vitro Diagnostic Devices Regulation (IVDR) 2017/746. The MedDO became effective on May 26, 2021, and the IVDO followed on May 26, 2022. For compliance with Swiss registration requirements, foreign medical device manufacturers are required to appoint a Swiss Authorised Representative (CH-REP).

Pharma Wizard Offerings

Strategic Regulatory Consulting Switzerland
Regulatory Affairs & Regulatory Intelligence Switzerland
Guidance on Registration Pathways and License Management
Comprehensive Dossier Management
Market Authorization Transfers
CE Marking Assistance
EMEA Region Filing Support

Pharma Wizard Advantages

In-depth local regulatory expertise and familiarity with SWISSMEDIC requirements
Skilled Regulatory team with extensive global experience
Collaborative and proactive working approach
Fast turnarounds ensuring quicker market entry
Constant alignment with local legislation and regulatory updates

Looking for Regulatory Support in Switzerland

Contact us now for Expert Guidance and Support