Operational Pharmacovigilance Activities
Case processing
We process adverse events arising from clinical trials as well as those arising from post-marketing sources.
Aggregate Safety Reports
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.
Literature Search and Review
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.
Narrative writing
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.
Pharmacovigilance Regulatory Intelligence
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.
Preparation of Risk Management Plans (EU RMP)
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.
Responding to enquiries from Competent Authorities
We prepare responses to questions received from the Health Authorities in regards to Pharmacovigilance.
Critical risk/benefit evaluations
We prepare critical benefit/risk evaluations to be integrated into the aggregate safety reports.
