Integral management of procedures and regulatory compliance.
Logistics, storage, and strategic distribution.
Integral solution for registration and compliance.
Formal establishment of operations in the country.
Commercial strategies for the target market.
Product analysis, sanitary classification, and applicable regulatory route in Mexico.
Integration, adaptation, and validation of the dossier according to Mexican regulations.
Presentation, follow-up, and attention to requirements during the evaluation process.
Release of corresponding registries, permits, or sanitary notices.
Support for modifications, renewals, and permanent regulatory compliance.
Fénix acts as a local regulatory ally in Mexico, comprehensively managing the procedures, files, and sanitary authorizations necessary for medicines and medical devices to comply with Mexican regulations and be entered, commercialized, and maintained in the country.
Regulatory compliance from the start, avoiding rejections, delays, or penalties.
Reduction of regulatory time and costs. Optimized processes with local experience.
A single point of contact in Mexico. Fénix centralizes management eliminating intermediaries.
Monitoring and management of renewals and changes to keep registries active.
Focus on the manufacturer's core business. The client produces, Fénix manages regulation.
Analysis of the entity type, operational scope, and most convenient structure according to the manufacturer's business model.
Creation of the company in Mexico with the manufacturer as legal representative and directly responsible.
Alignment of the subsidiary with applicable regulatory, sanitary, and administrative requirements.
Configuration of processes for importation, distribution, and direct sale to the final consumer.
Support during the start of operations and stabilization of the subsidiary in the Mexican market.
Fénix accompanies the international manufacturer in the creation, structuring, and start-up of their subsidiary in Mexico, allowing the manufacturer itself to act as legal representative and direct distributor to the final consumer.
Total legal and strategic control. The manufacturer maintains legal representation and key decisions.
Structured and orderly entry into the Mexican market. Reduced learning curve.
Operational and commercial independence. Ability to import and sell under their own subsidiary.
Reduction of legal, tax, and operational risks with expert accompaniment.
Solid foundation for long-term growth. Subsidiary prepared to scale portfolio.
Evaluation of the product, target audience, and direct-to-consumer sales model.
Definition of the scheme where Fénix acts as legal representative and operator in Mexico.
Preparation of permits, importation, storage, and final distribution.
Sales, billing, delivery, and customer service under the Fénix structure.
Analysis of results to decide on continuity, expansion, or transition to own subsidiary.
Fénix acts as legal representative and logistics manager in Mexico, allowing international manufacturers to market their products directly to the final consumer without needing to establish their own subsidiary in the country.
Immediate access to the Mexican market without initial investment in local legal structure.
Ideal entry model for market testing or gradual expansion.
Fénix as legal and operational representative, avoiding fiscal and logistic complexity.
Comprehensive management of the commercial chain from importation to final delivery.
Commercial speed and demand validation before a larger investment.
