With the implementation of the new pharmacovigilance legislation we have trained our experts to maintain compliance with the current drug safety/pharmacovigilance obligations.

We provide solutions for your pharmacovigilance system at national level in Bulgaria and Romania:

–    Appointment of local contact person for pharmacovigilance matters and deputy officer (24/7 service);
–    Weekly literature screening and translation services;
–    Communication point between the local authorities, local healthcare professionals, patients, client’s sales force and client’s QPPV;
–    Follow up of Individual Case Safety Reports;
–    Pharmacovigilance Trainings of client’s sales force;
–    Implementation of local SOPs.