A-consult   Regulatory affairs   Pharmacovigilance - General tasks - Our services  * Case handling  * Report writing  * QPPV  * Counselling & System support  * SME tailored solutions - EVMPD (new)   Foods   eCTD   Cosmetics   Brochures   Links   Report writing within Pharmacovigilance A-consult has a long tradition of writing reports including DSUR (former ASR) PSUR RMP in accordance with ICH and EU guidelines. We can write reports on your behalf or assist with the preparation of your reports. We can use your company's DSUR/PSUR template or templates developed by us. We can write the full report or write in cooperation with your people. It is your choice how much of the work you wish to do yourself and how much should be done by us. Taking the PSUR as an example, just send us your MA status, CCSI, your sales figures, and your line listings and summary tabulations and we will do the rest. As we are experienced in working with pharmacovigilance databases, we are also able to assist you with extracting line listings and summary tabulations from your safety system. The Risk Management Plan is required for new applications for marketing authorisations in the EU. This important document may be detailed and complex. When the submission of the application for a marketing autorisation approaches we can assist with the preparation and writing of the RMP and advise you whether or not a Risk Minimisation Plan is needed. A-consult a/s Gladsaxevej 3821 DK-2860 Søborg Denmark Tel: +45 38330080 Fax: +45 38330280 a-consulta-consult.dk     Business units: A-consult a/s A-pharmaconsult sas A-consult group Let us bring you to a safe landing