Artixio

Life Sciences Product Registration Services in Mexico

Trusted company in Mexico providing regulatory compliance, product approvals, and documentation consulting for life sciences. Streamline product registration and approval in Mexico with COFEPRIS-focused consulting for faster and compliant market entry.

Product Approval and COFEPRIS Liaison Services

Artixio is a preferred partner for the Lifesciences industry, including global brands, small-medium enterprises, and startups across pharmaceuticals, biotech, medical devices, diagnostics, cosmetics, nutraceuticals, animal feed, and veterinary. Our deep domain expertise, combined with our proven experience, is committed to providing you with seamless assistance throughout your regulatory journey. We provide regulatory intelligence-based based tailored solutions for COFEPRIS compliance and leverage your Life Sciences product and excel in its safety, quality, and marketing standards.

We at Artixio provide comprehensive services that include regulatory affairs, product registration, label, artwork, market access, post-market entry, and maintenance services, and many more in the life science sector in Mexico. Our customer-focused focused experienced regional team efficiently provides tailored solutions for your Life Sciences product compliance. Our tech-enabled team helps you expedite your product commercialization and help achieve sustained compliance in the Mexican market.

Regulatory Authorities for Product Registration in Mexico

COFEPRIS

SENASICA

Our Services

Regulatory Affairs
Product Registration
Market Access
IND (Investigational New Drug)
NDA (New Drug Application)
Regulatory Operations
Technical Writing
Regulatory Strategy
Market Access

Why Partner with a Compliance Consultant in Mexico

Expertise in Biopharmaceuticals, Devices, Cosmetics, Nutraceuticals, and Animal Health industries
ISO 9001:2015 certified quality assured team.
Proven success with product registrations and renewals in Mexico
Successful Approvals and Ongoing Product Lifecycle Maintenance for 200+ products.
Spanish-speaking regulatory experts ensuring smooth communication and submission
End-to-end support from product concept/prototype development, approval, and post-approval.
Strong understanding of local timelines, formats, and authority expectations
Trusted by global brands for reliable entry into the Mexican market

FAQs

How to approach the regulatory bodies in Mexico, and what are the modes of communication?
The regulatory body in Mexico is COFEPRIS, and it can be approached by a legal representative or consultant. Primary communications can be done through emails, online portals, or in-person query requests.
COFEPRIS takes a period of 6-12 months for the approval of Life Sciences products. However, there are fast-track options for critical and pandemic novel drug approval.
The fees associated with the COFEPRIS in Mexico are approximately 450 to 3,000 USD for pharmaceuticals, 850 to 1,500 USD for medical devices, and 500 to $2,000 USD for veterinary products. The cosmetics products are generally exempt from the approval fees by COFEPRIS but may be subject to importation charges.
COFEPRIS has its adverse event reporting system known as the Pharmacovigilance Unit (UFV). The adverse event can be reported by the healthcare professionals or MAH through the UFV online portal or through their reporting forms.

Industries We Serve in the Mexico

Pharmaceuticals

MedTech

Cosmetics

Nutrition

Biologics

Veterinary

Our Global Reach: Serving Life Sciences Clients Worldwide

India

Singapore

Mexico

Brazil

Vietnam

Malaysia

Argentina

Colombia

Taiwan

China

European

Thailand

Indonesia

Philippines

USA

Japan

Qatar

South Korea

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