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Our Services
Two specialized pillars that define a unique proposition in the Mexican regulatory market: Legal Affairs and Commercial Services under one roof.
Pillar I · Legal Affairs
Legal Affairs
We provide comprehensive regulatory and legal management for international pharmaceutical companies seeking to operate in Mexico with full legal and sanitary certainty.
Regulatory Affairs
We comprehensively manage all regulatory filings before COFEPRIS, FDA, EMA, and other international bodies. We accompany your company from initial assessment through obtaining and maintaining sanitary registrations.
- › Comprehensive management before COFEPRIS
- › Regulatory liaison with FDA and EMA
- › Strategic regulatory advisory
- › Monitoring and maintenance of filings
Legal Representation (Hosting)
We provide hosting services as Legal Representative for your products before Mexican health authorities, allowing international companies to meet legal representation requirements without needing an immediate local presence.
- › Legal representative before COFEPRIS
- › Full regulatory compliance
- › No need for a local office
- › Coverage of sanitary responsibilities
COFEPRIS Dossiers
We prepare and submit complete technical dossiers for obtaining sanitary registrations before COFEPRIS. Our experience ensures documentation meets all applicable technical and regulatory requirements.
- › Technical dossier preparation (CTD)
- › Complete regulatory documentation
- › Formal filing before COFEPRIS
- › Follow-up of the dossier in process
Copyright
We protect the intellectual property and brand rights of your products in the pharmaceutical and health industry in Mexico. We advise on trademark registration, patents, and protection of sector innovations.
- › Pharmaceutical trademark registration
- › Patent and innovation protection
- › Intellectual property in health
- › Distribution and licensing rights
Pharmacovigilance and Technovigilance
We monitor and report adverse events related to medicines and medical devices in accordance with COFEPRIS regulations. We help your company meet post-market surveillance obligations on an ongoing basis.
- › Adverse event detection and reporting
- › Post-registration obligation compliance
- › Periodic report management before COFEPRIS
- › Continuous surveillance systems
NOM Compliance for Labeling and Packaging
We verify that your products’ labeling and packaging meet applicable Mexican Official Standards (NOM) before commercialization. We reduce the risk of rejections and penalties for non-compliance.
- › Labeling review against NOM standards
- › Packaging and container verification
- › Preventive correction of non-conformities
- › Updates for regulatory changes
Comprehensive Regulatory Shielding
We design a comprehensive compliance strategy that protects your company against observations, penalties, and regulatory risk in Mexico. This service line has already been validated on projects with the tobacco industry.
- › Regulatory risk diagnosis
- › Tailored shielding plan
- › Support before authorities
- › Continuous updates for legal changes
Pre-Inspection Compliance Audits
We conduct internal audits ahead of sanitary inspections to identify and correct findings in advance. We prepare your team and documentation to confidently face authority visits.
- › Documentary and facility audit
- › Identification of critical findings
- › Corrective action plan
- › Mock inspection
Pillar II · Commercial Services
Commercial Services
We facilitate market entry into Mexico and commercial operations for international pharmaceutical and health companies, creating value at every stage of the process.
Market Entry Services
We design and implement market entry strategies for the Mexican pharmaceutical market. We identify opportunities, assess the regulatory and commercial environment, and execute plans to maximize the success of your market entry.
- › Pharmaceutical market analysis
- › Prior regulatory assessment
- › Strategy and launch plan
- › Strategic alliance management
Hosting for Local Operations
We host and manage the local operations of international companies in Mexico. We provide the operational, administrative, and regulatory infrastructure needed to operate in the Mexican market swiftly and securely.
- › Representative office in Mexico City
- › Administrative and tax management
- › Legal and regulatory compliance
- › Distribution operations support
Pharmaceutical Product Commercialization
We manage the commercialization of pharmaceutical and health products in the Mexican market. We have established distribution networks and deep sector knowledge to maximize your commercial presence.
- › Pharmaceutical distribution network
- › Relationships with chains and distributors
- › Commercial and sales management
- › Pricing and positioning strategy
Product Registration in Mexico
We comprehensively manage the sanitary registration process for your health products before COFEPRIS. From prior assessment through obtaining and maintaining the registration, we accompany every step of the process.
- › Prior product assessment
- › Application preparation and filing
- › Follow-up before COFEPRIS
- › Registration maintenance and renewal
Sanitary Registration Renewal
We manage the timely renewal of your sanitary registrations before COFEPRIS to avoid interruptions in your product commercialization. We track deadlines and requirements for every renewal.
- › Tracking of expirations and deadlines
- › Renewal documentation preparation
- › Filing and follow-up before COFEPRIS
- › Expiration prevention
Our Unique Proposition
"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
Legal + Commercial under one roof
The only agency in Mexico that integrates both specialties for a complete solution.
Experience with COFEPRIS, FDA, and EMA
Mastery of the leading international regulatory frameworks in the pharmaceutical sector.
WTC Mexico City · Floor 27
Presence at the heart of Mexico’s international business center.