If you typed Gotuzzo Asociados into a search box, you are probably building a CRO or site shortlist for Peru. This article uses only what is public about Gotuzzo Asociados (LinkedIn company page) and compares it with bioaccess®, the First-in-Human CRO for medical devices in Latin America since 2010. It is a practitioner comparison, not a teardown.
What Gotuzzo Asociados publishes
Gotuzzo Asociados S.A.C. is a Lima-based (Miraflores) clinical research services firm. Its public company profile describes services such as acting as legal representative before Peru’s INS, regulatory affairs, monitoring, investigational product import and translation. It appears as ROIC-96 in the INS register of research organizations (OIC).
Gotuzzo Asociados vs bioaccess®
| Dimension | Gotuzzo Asociados | bioaccess® |
|---|---|---|
| Core focus | Peru legal representation, regulatory, monitoring | First-in-human and early feasibility studies for medical devices |
| Geography | Peru (Lima) | Latin America, since 2010 |
| Device FIH track record | No named device first-in-human study found on the public pages reviewed | Published case studies on bioaccessla.com |
| After the trial | See provider site | Live multi-country sanitary registration and in-country holder service |
Where each one fits
If you need an INS legal representative and local regulatory and monitoring support for a drug study in Peru, Gotuzzo Asociados’ published services match.
If the job is a first-in-human or early feasibility study for a medical device, bioaccess® is a specialist built for exactly that, running device studies in Latin America since 2010. When the study ends, the same company can register and hold the device across the region through its market access service. Ask any CRO or site on your list, including Gotuzzo Asociados, for a named or de-identified device first-in-human study: device class, implant or not, number of patients, ISO 14155 monitoring plan and how the data was used in an FDA file.
For the Peru regulatory path, see CRO in Peru: the First-in-Human CRO on the INS file. Other Latin American CROs are compared in the guide to first-in-human device CROs in Latin America and on the bioaccess® compare hub.
Ready to compare a proposal? Request a first-in-human study proposal.
Facts from the Gotuzzo Asociados public pages linked above, Peru’s INS public registers and ClinicalTrials.gov, reviewed for bioaccess® competitive research (Oct 2026). Claims are theirs. No invented sponsors, prices or contacts.