Operational Pharmacovigilance Activities

We process adverse events arising from clinical trials as well as those arising from post-marketing sources.

We have a proven track record writing aggregate safety reports in both pre-authorization (DSURs, IND Annual Reports) and post-authorization (PBRERs, PADERs, SBR). The work is performed in accordance to good medical writing practices and according to the latest laws, regulations and guidelines released.

As per current legislation, we will develop a literature search strategy that best suits your product to efficiently identify the adverse reactions that require further processing and any other information that may be relevant for the critical risk/benefit evaluation and for the preparation of aggregate safety reports.

We are specialist in writing patient narratives to be used either as part of the case processing activities or to be presented in Clinical Study Reports.

Our company can assist you in ensuring worldwide compliance with the pharmacovigilance regulatory requirements. Our team will develop, for each of your products, a product-specific strategy for monitoring pharmacovigilance regulatory requirements taking into account the type of product and the regulatory status of the product in each country / region.

We can support you in writing the Risk Management Plan that is required for most of the products as part of a marketing authorization application.

We prepare responses to questions received from the Health Authorities in regards to Pharmacovigilance.

We prepare critical benefit/risk evaluations to be integrated into the aggregate safety reports.

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