Periodic safety update report (PSUR)
We ensure the entire pharmacovigilance process for your medicinal product. Furthermore, Diapharm has a current periodic safety update report, or: PSUR, on hand for numerous active pharmaceutical ingredients. Due to the pooling of reports for several medicinal products with the same active ingredient, we are able to offer these at very attractive rates. We would be happy to evaluate your company-specific data on an individual basis and prepare submittable PSUR for your human and veterinary medicinal products. In addition to the preparation of the periodic safety update report (PSUR) which has to be submitted regularly every 6, 12 or 36 months, we also assume responsibility for the required continuous monitoring of drug safety.
We research relevant sources of adverse drug reactions (ADR) in the scientific literature and evaluate the suspected cases that have been reported.
We prepare the ADR reporting documents (individual case safety report, ICSR) and submit them to the respective competent authorities or to the EMA via the EudraVigilance system.
Diapharm's PSUR preparation service stands out in the following ways:
- Regular literature research in Medline and Toxline (or further sources, if required)
- Review, evaluation and processing of case reports
- Preparation of a submittable periodic safety update report (PSUR)
Numerous current API-specific PSUR are available for purchase >> read more
