Do you need support in the area of pharmacovigilance? Our qualified team will be happy to help you report serious and previously unknown adverse drug reactions to Swissmedic. We will also act as your reliable partner when it comes to carrying out regular literature screening or submitting the necessary safety reports to Swissmedic.
If desired, a specialist from our team can assume the position of the responsible person for pharmacovigilance (PV) in your company.
A Swiss pharmaceutical company is legally obliged to appoint a professionally qualified person who is responsible for fulfilling the obligation to report adverse drug reactions to the Swiss Agency for Therapeutic Products, Swissmedic. On request, a qualified specialist from our team can take on the role of the responsible person for PV in your company to bridge short-term staff shortages or as a long-term solution.
A pharmaceutical company is obliged to report adverse drug reactions (ADR) to Swissmedic in accordance with the provisions of the Swiss Therapeutic Products Act and related ordinances, from the date of the application for marketing authorization until the expiry of the last marketed batch.
We can relieve the pressure on your pharmacovigilance department by ensuring compliance with reporting obligations and by reporting cases of adverse reactions to Swissmedic.
We will also forward cases from Swissmedic to your pharmacovigilance department.
We are happy to support you with the submission of periodic safety update reports (PSUR), risk management plans (RMP) and medicinal product signals to the Swiss Agency for Therapeutic Products, Swissmedic.
Scientific and medical literature is an important source for reports of suspected adverse drug reactions and safety signals. We can support your pharmacovigilance department with literature searches in Swiss journals.
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