- Home
- >
- All Countries
- >
- Argentina
Lifesciences Compliance Services In Argentina
From product concept to market entry and sustainable compliance, we ensure a streamlined regulatory pathway for your Life Sciences product in Argentina.
Argentina
Artixio serves as the strategic global partner, leveraging expertise to support your product’s journey to market. Our customer-focused, highly experienced team provides you with the right solution for your Life sciences product compliance in Argentina. We provide regulatory intelligence-based, tailored solutions to ensure full compliance with ANMAT. We assure that your product complies with all the safety, quality, and marketing standards in Argentina.
Regulatory Authorities In Argentina
ANMAT
- ANMAT is the main regulatory authority in Argentina that regulates pharmaceuticals, biologics, medical devices, vaccines, cosmetics, and wellness products.
- ANMAT handles all the regulatory procedures for these Life Sciences products, such as registrations, GMP inspections, clinical trials approval, import-export compliance, marketing, and post-marketing surveillance.
- The labelling and nutritional compliance are overlooked by INAL, which is a part of ANMAT.
SENASA
- SENASA is known to regulate veterinary products, biologics for animals, animal food, and agricultural products.
- The quality, safety, and efficacy of these products are ensured by SENASA, by regulating the manufacturing, packaging, and marketing procedures.
Ensure Seamless Regulatory Compliance In Argentina with Artixio:
At Artixio, our dedicated, customer-focused, nimble team focuses on successful product registration and market access in Argentina. We assist in services such as regulatory affairs, product registration, label, artwork, market access, post-market entry, and maintenance services, and many more in the life science sector in Argentina. We help to easily navigate through the robust regulatory framework of ANMAT and SENASA regulations.
Why Trust Artixio with Your Regulatory Journey In Argentina?
End-to-End Support from Product Conceptualization to Launch and Post-Market Support
ISO 9001:2015, Quality Driven Services Platform
Flexible, strategic, timely, and quality submissions.
Well networked with regional health authorities and trade associations
Local specialized team with regulatory intelligence-based strategies in Argentina with proven experience of 15-30 years.
Customer-focused, Nimble, Flexible, and Detail-Oriented Team
Direct access to in-house ANMAT regulatory liaisons
Our tech-enabled team with a regulatory intelligence-driven solution ensures sustained compliance.
Our Services
Regulatory Affairs
Product Registration
Market Access
IND (Investigational New Drug)
NDA (New Drug Application)
Regulatory Operations
Technical Writing
Regulatory Strategy
Market Access
Industries We Serve in the European Union
Pharmaceuticals
MedTech
Cosmetics
Nutrition
Biologics
Veterinary
FAQs
1. How to approach the regulatory bodies in Argentina, and what are the modes of communication?
The regulatory bodies in Argentina can be approached through their online portals or emails. Foreign manufacturers must appoint a local representative for their communication with the regulatory authorities in Argentina.
2. What is the fee for Life Sciences product registration with ANMAT in Argentina?
The fees associated with Life sciences product varies from product to product based on their risk level, such as the registration fees for pharmaceuticals range from $1,000 to $4,000, for medical devices, it ranges from $500 to $2,000 and for cosmetics and wellness products it ranges from $200 to $800.
3. How much time is taken by ANMAT for granting approval to the Life sciences product in Argentina?
The ANMAT approval time depends upon the product category, such as for generic pharmaceuticals it takes about 6-9 months, for innovative drugs it takes about 12-18 months, and for medical devices it takes about 3-12 months, depending upon the medical device class.
4. How can adverse events be reported in Argentina?
The adverse events in Argentina should be reported through the official pharmacovigilance system of ANMAT on the online portal of ANMAT. These adverse events are reported by the healthcare professionals AND MAH. The adverse report submitted should be in Spanish.
5. How frequently should the approval license for marketing be renewed in Argentina?
The approval license for marketing in Argentina must be renewed before its 5-year validity period expiring.
Our Global Reach: Serving Life
Sciences Clients Worldwide
India
Singapore
Mexico
Brazil
Vietnam
Malaysia
Argentina
Colombia
Taiwan
China
Europe
Thailand
Indonesia
Philippines
USA
Japan
Qatar
South Korea
Insights from Artixio - Tips & Articles
Pharma Manufacturing Booms in
Hildalgo had good pharmaceutical infrastructure and supply chain capabilities, but with no foreign investment...
UK Releases Amendment &
In January 2025, MHRA UK released guidance on implementation of amendments to Medical Devices...
Artixio Announces Grant for
HYDERABAD, India - March 27, 2024 - Artixio, a leading compliance and commercial consulting...