Just four Notified Bodies according to MDR 2017 / 745 have been named up to...
The safety requirements for medicinal products are high. Swiss laws and regulations are constantly being adapted. Patients, specialists and authorities demand more and more information. Adverse effects must be reported to Swissmedic. We would be happy to advise you.
Use our experience and know-how on a strategic level:
• Evaluation and optimisation of existing pharmacovigilance systems for Swiss pharmaceutical companies
• Development of new pharmacovigilance systems including contracts and documentation
• Providing the function of Responsible Person PV in Switzerland
We would be delighted to support you with your daily business:
• Receiving and processing ADR notifications from Switzerland
• Carrying out regular literature searches for Switzerland
• Review and submission of PSURs/PBRERs and RMPs
This white paper highlights what it takes to bring a drug to the Swiss market,...
For medicinal products used solely by medical personnel, the Information for Professionals can now be...
Swissmedic has introduced the principle of capping in response to the rise of fees for...