The Agency Defining
a New Experience
in Regulation.
We unite Legal Affairs and Commercial Services to help companies build long-term international partnerships in the Pharma and Health industry.
Our Services
Two pillars. One integrated solution.
AL-LO MED’s unique proposition unites legal and commercial expertise to support you through the entire market-entry cycle.
Pilar I
Legal Affairs
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.
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.
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.
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.
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.
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.
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.
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.
Pilar II
Commercial Services
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.
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.
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.
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.
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.
Regulatory Assessment
Ready to enter the Mexican market?
Request a free regulatory assessment. Our specialists will guide you every step of the way.