The identification of reportable Individual Case Safety Reports (ICSRs) and the detection of new safety is crucial for ensuring compliance with regulatory legislation across the world.

To ensure your pharmacovigilance operation is compliant with the standards of international regulatory authorities, our skilled team members can guide and assist you end-to-end.

For tracking of safety profile and risk-benefit ratio of a pharmaceutical product, scientific and medical literature is an important source of information, especially in connection to the identification of novel safety signal or developing safety issues.

In accordance with the regulatory guidelines, MAH shall focus on regional scientific and pharmaceutical publications in nations where the clients have marketing authorizations for pharmaceutical product, regardless of the product’s commercial position.

The MAHs with authorized products in EU, requires weekly monitoring and reviewing of the EudraVigilance Medical Literature Monitoring (MLM) list, maintained by the European Medicines Agency (EMA), for ICSRs identified in the literature, if the product(s) is (are) included in the list of active substances.