COMPLIANCE & OVERSIGHT
Regulatory Affairs
As a Laboratoire Exploitant in France, we are responsible for the regulatory compliance of the medicines we distribute. This status underlines our commitment to meeting the highest standards of safety, efficacy, and regulatory oversight in the pharmaceutical industry.
Strategic Regulatory Planning
A well-defined regulatory strategy is essential to pharmaceutical success. We collaborate closely with partners to develop regulatory plans that align with business objectives and stringent Health authority requirements.
Regulatory Submissions and Dossier Preparation
We provide expert support in the submission of marketing authorization (MA) dossiers, ensuring compliance with the requirements of regulatory agencies such as the European Medicines Agency (EMA) and national authorities like the French National Agency for Medicines and Health Products Safety (ANSM). Our role is to assist pharmaceutical companies in compiling and presenting scientific data/clinical trial results, facilitating a smoother and more efficient review process.
Liaison with Regulatory Authorities
Maintaining clear and effective communication with regulatory bodies is essential. Our team acts as an intermediary, managing correspondence, addressing queries, and providing necessary clarifications to expedite approvals.
Regulatory Intelligence & Compliance Monitoring
Intsel Chimos provides constant intelligence services, monitoring legislative changes to ensure partners remain informed and compliant.
