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.

Services We Offer

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

Regulatory Affairs Lifecycle in Mexico

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.

What types of products require COFEPRIS approval?

COFEPRIS regulates pharmaceuticals, biologics, medical devices, health supplements, cosmetics, and certain food products. Each category has specific submission and approval requirements.

Can I market my product in Mexico if it is approved in another country?

Approval in another country may streamline the process, but Mexican authorities require a separate approval. Artixio helps adapt your existing documentation for local compliance.

How can I maintain regulatory compliance in Mexico once my product is approved?

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.