Health registration processing
We manage new health registrations for medical devices and pharmaceuticals before COFEPRIS.
Services
Specialized regulatory services
We support every stage of the health regulatory cycle in Mexico, from initial registration before COFEPRIS to ongoing compliance with your obligations.
Ownership and legal domicile
We provide a legal domicile for the ownership of health registrations in Mexico under an independent and secure scheme.
Regulatory representation
We act as legal representatives before the Mexican health authority (COFEPRIS) for all types of regulatory procedures.
Health officer
We register the health officer in accordance with the applicable regulatory requirements.
Pharmacovigilance and Technovigilance Unit
We manage the registration of the Head of the Pharmacovigilance or Technovigilance Unit and compliance with related obligations.
Pharmacovigilance and Technovigilance reports
We prepare the pharmacovigilance and technovigilance reports required for health registration renewal processes.
End-to-end process
Comprehensive Management of Health Registrations
We coordinate every phase of the procedure — from the initial analysis to support before the authority — so your product reaches the Mexican market with technical and regulatory backing.
A
Regulatory analysis and classification
- Determination of the number of health registrations required.
- Regulatory classification of products.
- Regulatory strategy for market entry in Mexico.
B
Technical dossier preparation
- Request and review of technical documentation.
- Regulatory evaluation of the information provided.
- Selection of documents for official translation.
- Coordination of specialized translations.
- Management of certified copies.
- Full assembly of the health dossier.
C
Submission and follow-up before COFEPRIS
- Formal submission of applications.
- Regulatory follow-up of the procedure.
- Response to authority requirements.
- Support until the authorization is obtained.
Let's design your regulatory strategy
Tell us about your product and we'll respond with a tailored proposal.
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