What We Do
The regulatory landscape in Mexico and Latin America is complex, constantly evolving, and unforgiving of mistakes. A submission that is incomplete, mistimed, or misaligned with COFEPRIS expectations can add months to your timeline and significant cost to your study. Getting it right requires more than a checklist — it requires experience, relationships, and a deep understanding of how the system actually works.
At Althian, our regulatory team manages everything from initial strategy and dossier preparation to submissions, approvals, and post-approval lifecycle management. We handle the complexity so you don't have to.
Our Scope
We develop a tailored regulatory strategy for every study and product, mapping the most efficient path to approval given the specific requirements of COFEPRIS, the nature of the product, and the sponsor's timeline and objectives.
Our team prepares complete, submission-ready regulatory dossiers aligned with COFEPRIS requirements and international standards. We manage the full submission process, including follow-up with health authorities, response to queries, and tracking of approval timelines.
We manage all ethics committee submissions, amendments, and ongoing reporting throughout the life of your study — ensuring full compliance with Mexican bioethics regulations and ICH-GCP requirements.
Our team manages direct communication with COFEPRIS and other relevant health authorities on your behalf — responding to queries, attending meetings, and maintaining the kind of professional relationships that help move approvals forward.
Regulatory obligations don't end at approval. We manage renewals, amendments, variations, and ongoing compliance requirements to ensure your product or study remains in good standing with Mexican health authorities.
Go Deeper
Each of the following represents a specialized area within our regulatory affairs offering. Click to learn more.
Monterrey, México