EU–Mexico co-development: in vitro analytics, patented human GI tract simulator, plus ICH/Zone IVb stability protocol design & lab coordination

Partner with a Mexican public biotech center to de-risk your products for the Mexican market while generating credible evidence for EU stakeholders.

What we provide

• In vitro preclinical analytics: Method development/validation, impurity profiling, and quantitative assays via HPLC, LC-MS/MS, GC-MS, ICP-OES, spectroscopy; PCR/qPCR and microbiology for safety and quality.

• Patented human GI tract simulator: Controlled gastric/intestinal phases to quantify release, transformation, and bioaccessibility—ideal for comparing formulations, matrices, and encapsulation strategies before clinical work.

• Stability support for hot/humid markets: We design ICH-aligned stability protocols (including Zone IVb) and coordinate chamber studies with accredited Mexican laboratories; we handle sample logistics, method transfer, and QA review.

• Regulatory-ready outputs: Bilingual (EN/ES) reports, SOPs, raw data packages, and documentation aligned with COFEPRIS expectations and EU partner needs.

• Optional enablers: Pilot fermentation, downstream processing, microencapsulation, process engineering/DoE, and tailored training for technical teams.

Why Mexico
Access high-prevalence settings (e.g., Type 2 diabetes, NAFLD, dengue/arboviruses, HPV) for faster, relevant evidence and validate performance under Zone IVb conditions through accredited partners.

How collaboration works
Scope (EU-friendly hours) → NDA/MTA → protocol & milestones → partner lab selection/ethics as needed → execution with QA checkpoints → delivery of validated methods, datasets, and a regulatory-aligned dossier.

Ideal for EU companies seeking cost-effective, reliable evidence—and a trusted pathway to Mexico market entry—without overextending internal resources.