Home / Services
Our Services
Two specialized pillars that define a unique proposition in the Mexican regulatory market.
Legal Affairs
We provide comprehensive regulatory and legal management for your product in Mexico.
Regulatory Affairs
Strategic management of the regulatory requirements applicable to your product before Mexican health authorities.
- —Product regulatory classification analysis
- —Regulatory compliance strategy
- —Monitoring of applicable regulatory changes
- —Direct liaison with COFEPRIS
Legal Representation (Hosting Services)
We act as your company’s legal representative in Mexico for regulatory and commercial purposes.
- —Legal representation before health authorities
- —Legal and fiscal domicile in Mexico
- —Management of official correspondence
- —Permanent local point of contact
COFEPRIS Dossiers
Preparation and submission of technical dossiers for product approval before COFEPRIS.
- —Technical dossier preparation (CTD)
- —Document translation and adaptation
- —Filing and follow-up of the process
- —Response to observations and requirements
Copyright
Protection of the intellectual property associated with your product in Mexican territory.
- —Registration of works and packaging materials
- —Labeling and design protection
- —Intellectual property advisory
- —Defense against infringement
Commercial Services
We facilitate market entry and commercial operation of your product in Mexico.
Market Entry Services
Design and implementation of your product’s market entry strategy in Mexico.
- —Market study and commercial feasibility
- —Positioning strategy
- —Identification of commercial partners
- —Launch plan
Hosting Services for Local Operations
Operational support for establishing and running your operation in Mexico.
- —Local operations management
- —Logistics and distribution coordination
- —Ongoing administrative support
- —Liaison with local suppliers
Product Commercialization (Pharmaceutical Industry)
Comprehensive support for commercializing pharmaceutical products in Mexico.
- —Commercialization strategy
- —Distribution channel management
- —Commercial regulatory compliance
- —Market performance monitoring
Product Registration in Mexico
Full management of your product’s sanitary registration process in Mexico.
- —COFEPRIS sanitary registration management
- —Associated import procedures
- —Renewals and updates
- —Post-registration follow-up
Proposed Additional Services
The following services address common industry needs but have not yet been formally validated — pending approval.
- • Pharmacovigilance and Technovigilance
- • Sanitary registration renewal
- • NOM compliance — labeling and packaging verification
- • Comprehensive regulatory shielding
- • Pre-inspection compliance audits
"AL-LO MED is the only regulatory agency with a truly unique proposition: uniting Legal Affairs and Commercial Services to help companies enter the Mexican market."Request an Assessment