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Preparing and submitting regulatory submissions: Preparing and submitting documents and applications to obtain regulatory approvals and clearances, such as licenses, permits, and certifications.

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Supporting product registration: Assisting in registering products and services in various countries and jurisdictions, including obtaining the necessary permits and certifications.

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Monitoring and reporting on regulatory changes: Keeping abreast of changes in regulations and ensuring that products and services remain in compliance.

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Facilitating inspections and audits: Preparing for and assisting with regulatory inspections and audits, and responding to regulatory questions and inquiries.

Evaluate

Evaluating regulatory requirements: Identifying and assessing the regulations and laws that apply to a product or service

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

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Wide Spectrum of Health Products

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New Drug

Complete Regulatory Affairs Management

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Marketing Authorizations

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