Pharmacovigilance

We provide a broad spectrum of services including local QPPV and Safety Officer nomination, PSMF Creation and management, Local Literature screening, case processing and reconciliation, PV auditing as well inspection readiness support, PV Quality System establishment, Special programs PV management, PV trainings and Regulatory Intelligence. 

We provide tailored RA solutions within the MEA region for Bio-Pharmaceutical and Pharmaceutical companies including Dossiers preparations and submissions, MA obtaining and renewal, Variations management, importation approvals, RA vendor management and RA Auditing.

In collaboration with our engineering partners, we provide the services for pharmaceutical plants in the region including design and Execution of Pharmaceutical, cosmetics and Nutraceutical plants as per the global and local standards in addition to engineering solutions to optimize the facilities layouts..

Through our experienced team we offer a variety of solutions for MI management at local level in MEA region staring from creating the local system and Standard Operating Procedures, management and processing of Medical Queries and information.