Pharmacovigilance Systems
Set up and Maintenance of Pharmacovigilance Systems (PSMF)
We can set up your pharmacovigilance system, including all the necessary documentation (Pharmacovigilance System Master File, SOPs) in accordance with the regulations and national and international standards in force. We can also assist you with the maintenance of such system
SOP Pharmacovigilance / Safety Procedure Writing
We have extensive experience in developing Pharmacovigilance operating procedures such as Standard Operating Procedures (SOPs), Working Instructions and Safety Management Plans. We also provide assistance with the review and update of existing procedures.
Preparation of Safety Data Exchange Agreements (SDEAs)
It is essential to develop agreements that define the responsibilities of each partner with respect to each of the pharmacovigilance activities. A professionally written SDEA ensures regulatory compliance and avoids duplication of pharmacovigilance activities by different partners. Contact us.
EudraVigilance registration and XEVMPD submissions
We can assist with the registration into the EudraVigilance system in order to fulfil the ICSR electronic reporting requirements in E2B format as well as with the submission of data into the extended EudraVigilance Medicinal Product Dictionary (XEVMPD).
