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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


Development Safety Update Report


Qualified Person for Pharmacovigilance


Individual Case Safety Report


Local Safety Responsible


Pharmacovigilance System Master File


Periodic Safety Update Report


Periodic Benefit-Risk Evaluation Report


Suspected Unexpected Serious Adverse Event


Risk Management Plan


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

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New Drug

Complete Regulatory Affairs Management

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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!

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If you have questions or inquiries about the regulatory process with AcedrA, leave us a message and we'll get back to you.

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