Regulatory mastery

At the core of our organization, our specialized regulatory team demonstrates extensive expertise encompassing advanced therapies, consumer healthcare products, as well as pharmaceutical and hospital products. This wealth of knowledge is our asset for close collaboration with our partners, aiming to develop optimal regulatory strategies.

Custom Regulatory Solutions

We recognize the paramount importance of a robust regulatory strategy. Leveraging our sharp expertise in the specific regulatory frameworks of Algeria and Tunisia, along with our firmly established institutional connections, we work in harmony with your requirements to shape tailored strategies. Our close relationships with regulatory authorities and our deep understanding of the field allow us to design approaches adapted to each market, ensuring that your goals align with the most current and relevant regulatory guidelines.

International Coordination

At our central headquarters, our team orchestrates collaboration among our locally active regulatory experts. This methodology ensures consistency in the quality of our actions, regardless of the market we target. This synergy of skills enables a harmonized execution and uniform efficiency in our regulatory efforts, transcending the specificities of each market.

Adaptable to Your Requirements

We are attentive to your regulatory requirements. Whether it's strategic guidance or operational assistance, our team adapts to provide the necessary services.

Situational Diagnosis

We conduct a meticulous analysis of your context, pinpointing areas in need of improvement with precision. Furthermore, we perform comprehensive audits of your documentation, ensuring that each element is rigorously examined. Our meticulous approach ensures that your files are complete, compliant, and ready to meet the regulatory standards in force in Algeria and Tunisia.

Regulatory Strategy and Procedures

We design and process requests for the market authorization of pharmaceutical products, encompassing specific procedures for each product. Our diligent team works in close collaboration with the relevant authorities to ensure that your products meet the rigorous regulatory requirements of Algeria and Tunisia.

Post-Approval Activities

We maintain ongoing dialogue with regulatory bodies while ensuring linguistic reviews, precise translations, and the creation of impactful visual materials. Moreover, we ensure that promotional materials are fully compliant with regulatory standards. Our close interaction with authorities allows us to promptly address compliance needs and refine all materials that contribute to the success of your products in the markets of Algeria and Tunisia.

Regulatory Monitoring and Impact Assessment

We remain constantly vigilant to changes in the regulatory landscape, closely monitoring developments that could impact your operations. We conduct a thorough assessment of the potential impact of these changes on your activities to ensure that your strategy remains aligned with new regulatory directions and that your products continue to thrive in the markets of Algeria and Tunisia.