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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
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
- Local expertise in Mexico’s regulatory environment
- End-to-end support from product concept to market entry
- Strong relationships with Mexican regulatory authorities
- In-house team with 30 years of experience
- Flexible services to suit your business needs
- Focused on compliance, speed, and successful approvals
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.
Still Have Questions ?
Get expert answers tailored to your needs.
Industries We Serve in the Mexico
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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