althian
Product Registration & Marketing Authorizatio
Secure market access with expert regulatory support tailored to Latin America. At Althian, we manage the complete lifecycle of product registration and marketing authorization for pharmaceuticals, biologics, and medical devices across Mexico and the broader LATAM region. Our team ensures that your applications—whether initial registrations, renewals, or post-approval variations—are submitted accurately, efficiently, and in full compliance with local regulatory requirements.
We work closely with health authorities such as COFEPRIS (Mexico), ANVISA (Brazil), INVIMA (Colombia), DIGEMID (Peru), and others to streamline approvals and maintain ongoing compliance for your products in target markets.
Initial Product Registration
Preparation and submission of complete registration dossiers tailored to country-specific formats and technical requirements.
Coordination with regulatory agencies to facilitate timely review and approval.
Support for both national and regional registration pathways, including reliance mechanisms and fast-track options.
Renewals & Maintenance
Management of renewal timelines and documentation to ensure uninterrupted market authorization.
Monitoring of regulatory changes that may impact renewal requirements or product classification.
Strategic planning to align renewals with lifecycle updates and commercial goals.
Variations & Amendments
Submission of post-approval changes including formulation updates, manufacturing site changes, labeling modifications, and safety-related amendments.
Regulatory impact assessments to determine classification of variations and required documentation.
Liaison with health authorities to resolve queries and expedite approval of changes.
Regional Coordination Across LATAM
Harmonization of registration strategies for multi-country submissions.
Translation and localization of technical documents for Spanish- and Portuguese-speaking markets.
Strategic advisory on navigating regulatory differences across Latin America.
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