Regulatory Support
We have extensive experience in building regulatory strategies customized according to our client’s regulatory needs in the MENA region. Our team has a comprehensive understanding of regulatory regulations, guidelines, and requirements applicable to regulatory submissions in the region.
Our Regulatory Champions will
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
New Drug
Complete Regulatory Affairs Management
Marketing Authorizations
Strong Network with the Regulatory Bodies in the MENA region
Through strategic guidance, risk identification, and management, we strive to secure regulatory approvals for our clients quickly and efficiently so they can seize opportunities as they arise. With our regulatory affairs services, businesses can rest assured that their products and services are compliant with regulatory requirements and that they can quickly access new markets in the Middle East and North Africa region.
Our regulatory affairs team is dedicated to helping clients understand the regulatory landscape of this diverse region, develop regulatory strategies, identify risk areas, and ultimately ensure regulatory compliance. Through regulatory and scientific expertise, we help our clients gain access to new markets in the Middle East and North Africa region by helping them navigate the complex regulatory environment.
Our regulatory affairs professionals strive to provide industry-leading regulatory solutions that enable businesses to take advantage of opportunities available throughout the region.
Contact us today to learn more about how our regulatory affairs services can help you succeed in the Middle East and North Africa region. Together, let's unlock the potential of regulatory compliance!
If you have questions or inquiries about the regulatory process with AcedrA, leave us a message and we'll get back to you.
