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   Counselling & System support within Pharmacovigilance Do you need advice or coaching? Do you need input to your internal discussions or discussions with the competent authorities? A-consult has several years of pharmacovigilance expertise from working with small and large pharmaceutical companies. The practical experience is combined with continuous training and participation in national and international meetings and conferences. This forms the basis of our counselling service. Independent, professional competence is of vital importance to any debate. System support Pharmacovigilance System Master File The Pharmacovigilance System Master File will gradually replace the Detailed Description of the Pharmacovigilance System and must be fully implemented in mid-2014. We will help you to stay in compliance. SOP writing Do your SOP's need a quality check? We can review and update your exisiting SOP's for compliance with current legislation. We use our experience to advise how to build an efficient and compliant system. Pharmacovigilance agreements A Marketing Authorisation Holder rarely works alone. Partners and consultants are often engaged. The competent authorities expect to see pharmacovigilance agreements which clearly describe the division of responsibilities for pharmacovigilance activities. Our staff has years of experience in writing and negotiating pharmacovigilance agreements. A-consult also offers: Database solution Registration of your company in Eudravigilance Training 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