Our Approach
Registration is a process. We manage every step of it.
Product registration in Mexico is not a simple filing exercise. COFEPRIS has specific, detailed requirements for every product category — pharmaceuticals, biologics, and medical devices each follow different pathways, with different documentation requirements, review timelines, and post-approval obligations.
At Althian, we work from your sponsor-provided technical documents to prepare complete, submission-ready dossiers tailored to COFEPRIS requirements. We manage the full DIGIPRIS submission process, track review progress, respond to health authority queries, and follow through to approval — and beyond.
What We Cover
All product types. All registration stages.
New Product Registration
We prepare and submit complete registration dossiers for new products entering the Mexican market, managing the full COFEPRIS review process through to marketing authorization.
Renewals and Amendments
We manage registration renewals and post-approval amendments — including labeling changes, manufacturing variations, and indications updates — ensuring your product remains in good regulatory standing.
Health Authority Query Management
When COFEPRIS raises questions during review, we prepare timely, thorough responses that keep your submission moving forward. Our experience with health authority communication helps minimize delays and misunderstandings.
Why Althian
We know COFEPRIS because we work with them every day.
Regulatory approval in Mexico is not just about submitting the right documents. It is about understanding how COFEPRIS reviewers think, what they prioritize, and how to present information in a way that minimizes back-and-forth and keeps your timeline on track.
With over 15 years of experience managing COFEPRIS submissions across all product categories, Althian brings a level of familiarity and practical know-how that makes a real difference in approval timelines and outcomes.