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Our Expertise will unlock your Access
MENA region expert
When it comes to regulatory affairs in the Middle East and North Africa region, it can be a complex and challenging process. But when regulatory compliance is met and standards are upheld, businesses across the region have access to untapped potential. Our team of regulatory affairs experts helps our clients navigate the intricate regulatory frameworks of this dynamic region to ensure that their products and services meet regulatory requirements. With a deep understanding of local regulatory details, our experienced regulatory professionals provide comprehensive regulatory and compliance services that help businesses reduce risk and maximize their potential in the Middle East and North Africa region.
Our Pharmacovigilance Activities
DSUR
Development Safety Update Report
QPPV
Qualified Person for Pharmacovigilance
ICSR
Individual Case Safety Report
LSR
Local Safety Responsible
PSMF
Pharmacovigilance System Master File
PSUR
Periodic Safety Update Report
PBRER
Periodic Benefit-Risk Evaluation Report
SUSAR
Suspected Unexpected Serious Adverse Event
RMP
Risk Management Plan
PASS
Post Authorization Safety Study
Ask our experts if you would like to understand the regulatory pathway.
Just match the type of your product with the right service that would like to get.
Wide Spectrum of Health Products
Complete Regulatory Affairs Management
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Ceci est un paragraphe. Cliquez sur "Modifier le texte" ou double-cliquez sur la zone de texte pour commencer à modifier le contenu et assurez-vous d'ajouter tous les détails ou informations pertinents que vous souhaitez partager avec vos visiteurs.