Regulatory Affairs Services in Argentina for Life Sciences

Supporting your product journey in Argentina with local insight, regulatory clarity, and steady hands-on guidance.

Services We Offer

Practical regulatory support for complex market realities:

At Artixio, we work with global and regional life sciences companies to bring products to Argentina without delays or compliance gaps. We understand how ANMAT and related authorities operate — and what it takes to register, update, or maintain products in this market. From dossier adaptation to renewal handling, we help reduce friction in every phase of your regulatory journey.

Whether you’re filing a drug application, submitting a dossier for a medical device, or preparing a cosmetic notification, we tailor our process to meet Argentina’s legal, linguistic, and technical expectations — without overwhelming your internal teams.

Regulatory Authorities in Argentina

Regulatory Body	Focus Area
Administración Nacional de Medicamentos, Alimentos y Tecnología Médica(ANMAT)	Pharmaceuticals, medical devices, cosmetics, food supplements
Servicio Nacional de Sanidad y Calidad Agroalimentaria(SENASA)	Veterinary products, animal nutrition
Instituto Nacional de Alimentos(INAL) - (within ANMAT)	Nutrition products, labeling, safety evaluation

Regulatory Affairs Lifecycle in Argentina

1. Market Feasibility & Regulatory Assessment

Start with understanding if your product category is accepted under current ANMAT guidelines and what documents or testing will be expected.

2. Dossier Preparation & Translation (if required)

Compile technical, clinical, and administrative documentation based on local standards. Spanish translations are often required for submission.

3. Local Representation & Submission Filing

Appoint a local agent or representative (when applicable). File the application with ANMAT or other relevant agencies through their specified portals.

4. Product Evaluation by Regulatory Authorities

The regulatory body reviews the documentation, conducts technical or safety assessments, and may request additional clarifications.

5. Registration Certificate Issuance

Once approved, you receive a registration or marketing authorization number. This is a legal approval to import, manufacture, or sell in Argentina.

6. Post-Approval Compliance & Modifications

Monitor for regulatory updates, manage renewals, report any adverse events, and notify authorities of changes to formulation, packaging, or ownership.

Why Artixio for Argentina Regulatory Affairs

FAQs

1. Do I need a local partner to register products in Argentina?

Yes, most registrations with ANMAT or SENASA require a local legal representative or affiliate. Artixio can assist with this setup.

2. How different are ANMAT requirements from EU or U.S. regulations?

ANMAT follows some global benchmarks but has its own dossier structure, language requirements, and labeling rules. Direct reuse is not always possible.