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Lifesciences Compliance Services In Mexico
From concept to commercialization, we assist in navigating the stringent regulatory process for life sciences products in Mexico.
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.
Ensure Seamless Regulatory Compliance In Mexico with Artixio
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 In Mexico
COFEPRIS
- COFEPRIS is responsible for the smooth regulation of the pharmaceuticals, medical devices, biologics, cosmetics, and wellness products in Mexico.
- It manages the approval, imports, exports, labeling and packaging, adverse events, and marketing of Life Sciences products.
- It ensures that there is strict compliance with the regulatory guidelines by the manufacturer.
SENASICA
- SENSICA regulates the veterinary and animal health care products in Mexico.
- It ensures timely compliance with the animal disease control and food safety regulations.
- It also coordinates with COFEPRIS for compliance with products that affect both animals and humans.
- SENSICA looks over all the regulatory requirements of the production, marketing, import, and export of veterinary products.
Why Trust Artixio with Your Regulatory Journey In Mexico?
Expertise in Biopharmaceuticals, Devices, Cosmetics, Nutraceuticals, and Animal Health industries
ISO 9001:2015 certified quality assured team.
Proven experience in successfully registering and maintaining 2000+ licenses
Successful Approvals and Ongoing Product Lifecycle Maintenance for 200+ products.
Local specialized team with regulatory intelligence-based strategies in Mexico with proven experience of 15-30 years.
End-to-end support from product concept/prototype development, approval, and post-approval.
Customer-focused, Nimble, Flexible, and Detail-Oriented Team
Hybrid-Local-Centralized Support across Regulatory functions
KPI based, continual process excellence
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 Mexico
Pharmaceuticals
MedTech
Cosmetics
Nutrition
Biologics
Veterinary
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.
How much time is required for the Lifesciences product approval by COFEPRIS in Mexico?
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.
What is the fee associated with the COFEPRIS in Mexico?
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.
How to report an adverse event in Mexico?
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.
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