Mandatory legal representation for foreign companies wishing to market regulated products in international markets. We act as your official representative before local regulatory authorities, ensuring technical compliance and streamlining the process of market entry and continued operation in the target country. 

Mandatory process for marketing products subject to sanitary, technical, or safety control. We manage every step of the registration with the relevant authorities, such as the FDA (USA), Health Canada (Canada), ISP and MINSAL (Chile), ANMAT (Argentina), DIGEMID (Peru), INVIMA (Colombia), SFDA (United Arab Emirates), among others. We act with technical accuracy and in-depth knowledge of the specific requirements of each country and product category, ensuring your company is legally authorized to operate in your target markets. 

We adapt your labels and packaging to meet the legal, technical, and linguistic requirements of each destination country, including multilingual labels. Our service includes full verification of layout, mandatory content, warnings, and specialized translations, in accordance with the regulations of the respective authorities. We ensure full compliance with local requirements such as nutritional labeling, mandatory warnings, regulatory symbols, and official language, helping to prevent customs holds and facilitating approval in audits and inspections. 

Specialized technical analysis to determine the best regulatory pathway for your product in international markets. We conduct classification studies and regulatory framing by product category and destination country.

Our support includes guidance on Good Manufacturing Practices (GMP, ISO 22716), assistance during audits and certifications, regulatory equivalence analysis between countries, and compliance requirements for international logistics of regulated products.

We also define the correct fiscal and technical codes (HS Code/Product Code) for each destination, ensuring legal entry and proper taxation, while preventing penalties.

Preparation and submission of mandatory import notifications required before a product enters a foreign country, as established by local regulatory authorities. In the U.S., we submit the Prior Notice to the FDA for food and beverage products. In other countries—such as Canada (via MyCFIA), the European Union (via TRACES), and Chile (via ISP/SAG), we provide full support in the preparation and submission of the required pre-authorization documents according to the product category. This process helps prevent customs delays and ensures sanitary compliance upon arrival. 

We prepare and manage the technical documentation required by international authorities to demonstrate the safety, traceability, and regulatory compliance of foreign suppliers. In the U.S., we follow FDA requirements through the FSVP – Foreign Supplier Verification Program. In Canada, we comply with the Preventive Control Plan (PCP) under the SFCR. For the European Union, Chile, and Mercosur countries, we support local importers in fulfilling their obligations with technical documentation, certificates, test reports, and evidence of Good Manufacturing Practices required for audits and sanitary clearances.

Drug listing with the FDA, including issuance of the NDC (National Drug Code) for over-the-counter (OTC) products such as homeopathic and herbal medicines. We handle the facility and manufacturer registration, designation of a US Agent when required, and the electronic SPL submission of the product.

We ensure that your product is properly listed in the FDA’s official database in accordance with applicable regulations, avoiding customs holds and enabling legal commercialization in the U.S., even for non-prescription products.

Specialized technical support for companies with products held at customs or under sanitary inspection in the U.S., Canada, Europe, or Latin America. We assist in cases of detention due to incorrect labeling, missing Prior Notice, unregistered facility, irregular formulation, or lack of required technical documentation.

We review and correct labels, prepare technical justification letters, submit documentation through FDA ITACS, and, when necessary, create or revise Standard Operating Procedures (SOPs) requested in corrective audits or as part of FSVP compliance plans.

Our goal is to ensure the fast release of your goods, resolving technical issues and guiding both the exporter and importer through every step of regulatory clearance.