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Pharmaceutical Regulatory Consultant in Mexico
COFEPRIS-Focused Regulatory Support for Pharmaceutical Products in Mexico
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Our Pharmaceutical Regulatory Services in Mexico
Expanding your pharmaceutical product into the Mexican market requires strict compliance with COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios). At Artixio, we help pharma companies streamline the registration process, reduce approval delays, and stay compliant with all regulatory updates.
We support companies of all sizes — from local manufacturers to international brands — with COFEPRIS submissions, renewals, modifications, GMP support, and more.
Artixio’s Approach
Product Development → Approval → Commercialization
| Phase | Our Role |
|---|---|
| Product Development | Assess COFEPRIS requirements early, provide regulatory feasibility input |
| Approval | Handle end-to-end submission, coordination, and approval process |
| Commercialization | Support post-approval compliance, renewals, and market access needs |
COFEPRIS Process for Pharmaceutical Products
| Stage | What Artixio Does |
|---|---|
| Pre-Submission | Review formulation & documentation, identify gaps, prepare regulatory roadmap |
| Submission | Compile and submit dossier in required formats (Module I–V as per CTD), coordinate with COFEPRIS |
| Post-Submission | Track progress, respond to information requests, support during technical evaluations |
Product Types We Support
- New Chemical Entities (NCEs)
- Generic Drugs
- Radiopharmaceuticals
- Fixed-dose Combinations
- Orally administered, injectable, and topical products
Why Work with Artixio in Mexico?
15–30+ years of pharma regulatory experience
Strong track record with COFEPRIS approvals
Experts in NCEs, Generics, 505(b)(2), and complex drugs
Local presence with global regulatory insights
ISO 9001:2015 quality-backed service delivery
Project-based or dedicated FTE engagement options
Proven support from development to post-launch
FAQs
1. How long does it take to get a pharmaceutical product approved by COFEPRIS?
Approval timelines vary by product type. On average, generic drug approvals can take 4–8 months, while new molecules may take longer depending on dossier completeness and regulatory pathway.
2. Is a local Mexican registration holder mandatory for product approval?
Yes. COFEPRIS requires a local legal representative (holder) for marketing authorization. Artixio offers local representation services to support foreign manufacturers.
3. I’m planning to enter the Mexican market for the first time. Where do I start?
Start with a product classification check and regulatory pathway mapping. Artixio helps you assess COFEPRIS requirements based on your product type and global status.
4. My product falls under 505(b)(2) in the US. Is there an equivalent in Mexico?
Mexico doesn’t use the same regulatory term, but we assess whether your data package qualifies for simplified approval under COFEPRIS pathways.
5. Will Artixio handle communication with COFEPRIS directly?
Yes. If you appoint us or our local partner as your registration holder, we manage all COFEPRIS interactions on your behalf.
Regulatory Expertise Across
Multiple Countries
India
Vietnam
Mexico
Vietnam
United States
Brazil
Europe
Malaysia
Taiwan
China
Thailand
Philippines
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