Artixio

Regulatory Affairs Consulting for Life Sciences in Mexico

Get expert support to navigate Mexico’s regulatory requirements for life sciences. We make compliance simpler so you can focus on your product’s success.

Regulatory Affairs Services in Mexico

At Artixio, we specialize in helping life sciences companies navigate Mexico’s regulatory requirements. We know the challenges of getting products approved and into the market, so we provide hands-on support to make the process easier. Whether you’re dealing with pharmaceuticals, medical devices, or nutrition products, we work alongside you, from the very first step of product registration to monitoring your product after it hits the market.

Regulatory Authorities in Mexico

COFEPRIS

The primary body for regulating pharmaceuticals, medical devices, and health-related products.

SAGARPA

Responsible for agricultural products, food safety, and quality control.

SE

Regulates packaging, labeling, and product import/export compliance.

SSA

Regulates health standards for health-related products.

Regulatory Affairs Lifecycle in Mexico

Understand the specific Mexican requirements for your product’s classification, whether it’s a drug, device, or food product, and define the applicable regulatory route.
Prepare and submit all required documentation to COFEPRIS, SAGARPA, or other relevant authorities.
Mexican authorities review the product’s compliance with local health and safety standards.
Get approval and product license from the appropriate regulatory body.
Once approved, distribute the product while maintaining compliance with local laws.

Why Artixio for Regulatory Affairs in Mexico

FAQs

Are there any specific labeling requirements in Mexico?
Yes, all products must comply with COFEPRIS and SAGARPA regulations for labeling. This includes ensuring proper translations, ingredient disclosures, and health claims that align with Mexican health standards.
COFEPRIS regulates pharmaceuticals, biologics, medical devices, health supplements, cosmetics, and certain food products. Each category has specific submission and approval requirements.
Approval in another country may streamline the process, but Mexican authorities require a separate approval. Artixio helps adapt your existing documentation for local compliance.
We help you stay compliant through regular reviews and updates on Mexican regulations. Artixio also assists with post-market surveillance and reporting requirements to ensure continued market access.

Still Have Questions ?

Get expert answers tailored to your needs.

Industries We Serve in the Mexico

Pharmaceuticals

MedTech

Cosmetics

Nutrition

Biologics

Veterinary

Expert Regulatory Services To Streamline Compliance

Regulatory Intelligence & Strategy
Medical & Technical Writing
Publishing & Submission
Product Registration
Investigation New Drug Application (IND)
New Drug Application (NDA)
Post Approval Lifecycle Maintenance
Artwork and Label Review
Ad Promo Review

Regulatory Affairs Across Multiple Countries

India

Singapore

Mexico

Brazil

Vietnam

Malaysia

Argentina

Colombia

Taiwan

China

European

Thailand

Indonesia

Philippines

USA

Japan

Qatar

South Korea

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