Why It Matters
A delayed shipment is a delayed study.
For international sponsors conducting clinical trials in Mexico, the logistics of moving investigational medicinal products across the border is one of the most underestimated sources of delay. Import permits, customs documentation, cold chain compliance, and regulatory alignment with COFEPRIS all need to be in place before a single vial arrives at a site.
At Althian, we manage this process end to end — from obtaining the necessary regulatory authorizations to coordinating the documentation required for import and export — so your investigational products move through the system efficiently and your study stays on track.
What We Cover
Import. Export. Everything in between.
Import Support
We manage all regulatory requirements for bringing investigational products into Mexico, ensuring every shipment is authorized, documented, and compliant with COFEPRIS requirements before it arrives.
- COFEPRIS import permit management
- Investigational product authorization
- Cold chain and temperature compliance documentation
- Customs documentation preparation
- Coordination with site receiving teams
Export Support
When samples, biological specimens, or investigational materials need to leave Mexico — for central lab analysis, return to sponsor, or transfer to another study site — we manage all regulatory and customs documentation required for compliant export.
- Export regulatory authorization
- Biological specimen export documentation
- Chain of custody management
- Coordination with receiving laboratories or sites
- Compliance with international shipping regulations
Beyond the Basics
Full supply chain regulatory support.
Investigational Product Accountability
We maintain complete documentation of investigational product receipt, storage, dispensing, and return or destruction — ensuring full accountability in compliance with GCP and COFEPRIS requirements.
Regulatory Timeline Management
We build import and export timelines into the overall study schedule from day one, anticipating lead times for permit approvals and customs clearance to avoid last-minute delays that impact site activation and patient enrollment.
Why Althian
Supply chain delays don't happen on our watch.
International sponsors often underestimate how long it takes to get investigational products into Mexico. Import permits, customs clearance, and COFEPRIS authorizations all have their own timelines — and they don't wait for your study schedule.
Althian builds regulatory logistics into the study plan from the start. We know the timelines, we know the requirements, and we know how to keep your supply chain moving so your sites are never waiting on product.