Regulatory Pathway Determination

We provide end-to-end support selecting the most effective and efficient regulatory pathway for your product. By analyzing regional regulations, risk levels, and data requirements, our team identifies the optimal route to expedite approvals. 

Regulatory Dossier Preparation and Submission

 We expertly compile essential product information, from clinical data to manufacturing protocols, presenting it in the required format and structure. We use our agency relationships to expedite reviews and ensure swift MENA approvals.

Labeling Review and Localization

Our team understands that an effective label does more than inform—it builds trust. We ensure that your product labeling resonates with regional consumer bases and complies with local linguistic and regulatory mandates. 

Consultation

 We deliver specialized regulatory affairs consultation meticulously crafted to navigate the dynamic complexities of healthcare product oversight. We devise bespoke strategies that optimize product registration, expedite approvals, and safeguard ongoing regulatory alignment. 

Active Regulation Tracking

Our specialized monitoring services keep you informed about new or updated regulations, policies, and guidelines across MENA jurisdictions. By providing regular intelligence reports and strategic advice, we enable agile adjustments to your product strategies, safeguarding compliance and fueling a competitive edge in rapidly shifting markets. 

​

Post-Market Services

Once your product hits the market, ongoing safety and performance monitoring becomes critical. Our services involve collecting, analyzing, and reporting real-world evidence to detect adverse events swiftly. We help you uphold compliance  and sustain long-term consumer trust in the MENA region.