We started when validating meant printing. We're still here because we evolved.

OqoTech was founded over 15 years ago, when the industry was still digesting 21 CFR Part 11 and GAMP 5 was the mandatory standard for any validation project. Since then, we've seen the arrival of the cloud, SaaS, artificial intelligence, and CSA. And we've seen what happens to companies that don't adapt.

The FDA doesn't ask the same questions it did ten years ago. Neither does the EMA. Inspectors from AEMPS, INVIMA, ANVISA, and COFEPRIS have evolved, and expectations regarding the documentation of computerized systems have changed radically. We've been to those inspections. We know the tough questions because we've heard them firsthand, in Madrid, Bogotá, Costa Rica, and Mexico City.

We are a team of consultants specializing in computerized system validation. We all worked in the industry before becoming consultants. We understand the pressure of an impending inspection, the problem of a legacy system no one wants to touch, and the frustration of an implementation project delayed because no one validated it on time.

We work with pharmaceutical laboratories, medical device manufacturers, biotechnology companies, and active ingredient companies in Spain, Portugal, and throughout Latin America—from Mexico to Argentina, including Colombia, Peru, Ecuador, and Brazil. This coverage isn't just a pretty map in a presentation. It's the result of real projects, real inspections, and clients who called us when they had a real problem.

Our advantage isn't size. It's specialization: we don't do everything, we do this very well. And we've been doing it for fifteen years while the industry changed around us.

We're still here because we've known how to evolve. Just as we ask our clients to do.