Our Approach
The decisions made in Phase I and Phase II shape everything that follows. Dosing ranges, safety profiles, go/no-go decisions — these are determined in early phase, and getting them right requires a level of operational precision and scientific rigor that leaves no room for error.
At Althian, we combine our deep regulatory expertise in Mexico with the clinical operations experience to execute early-phase studies efficiently, safely, and in full compliance with ICH-GCP, COFEPRIS, FDA, and EMA standards.
What We Offer
FIH trials mark the first administration of a compound in humans — and they require meticulous planning, risk mitigation, and real-time safety monitoring. Our team designs and executes FIH studies with the level of precision and care these studies demand, from protocol design through to final reporting.
We conduct Phase I trials to assess safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy volunteers or targeted patient populations. Our team designs customized protocols to determine optimal dosing, administration routes, and preliminary efficacy parameters — establishing the clinical viability of your compound before larger studies begin.
We support dose escalation studies to identify the maximum tolerated dose and establish safe therapeutic ranges. Our team uses stepwise escalation models and PK/PD data to guide dosing decisions at every step, keeping patient safety at the center of the process.
We design and execute BA/BE studies in compliance with COFEPRIS, FDA, and EMA requirements — a critical step for generic drug approvals and formulation development in the Mexican and LATAM markets.
Phase II studies confirm safety and gather initial efficacy data in specific patient populations. We collaborate with investigators to define meaningful endpoints and generate robust clinical evidence — helping sponsors make faster, better-informed go/no-go decisions.
Why Mexico
Monterrey, México