RC&C Consultores is the homegrown Ecuador shop that publishes “Holding de Registros” in so many words. The homepage registrossanitariosrcc.com (retrieved 23 August 2026) says they act as legal titulares before ARCSA so a foreign company can work with multiple distributors and not be tied to one. They also publish a BPADT-certified warehouse. That is a one-country holding + storage product. bioaccess® is the multi-country holder subscription that names ARCSA among 19 markets.
What RC&C publishes
Public facts on the homepage:
- More than 12 years obtaining sanitary registrations in Ecuador (their figure); they also cite experience with more than 1,400 registros sanitarios.
- ARCSA registros and notificaciones for devices, food supplements, foods, cosmetics, hygiene products, and medicines.
- Legal representation / holding / IP as a service tile.
- Explicit holding paragraph: they offer Holding de Registros so the foreign company keeps total control; they act as legal titulares before ARCSA; multiple distributors without being tied to any one of them.
- Bodega certificada BPADT (Buenas Prácticas de Almacenamiento, Distribución y Transporte) for devices and pharmaceuticals from receipt to delivery, under ARCSA rules.
- Contact published on-site: +593 99 777 3359 / +593 99 260 1838; asesoria@consultarcc.com. Named as RC&C Consultores, 2015 in the footer.
ARCSA issues the sanitary registry certificate in the name of the holder, who is responsible for its use (Resolución ARCSA-DE-026-2016-YMIH, reformed by ARCSA-DE-2023-033-AKRG, as cited on the bioaccess® IOR page). Registration must be held by a local Ecuadorian company — a single holder. That is why hosting plus warehouse is the independent analogue, and why a distributor-as-titular is a single point of failure. Ecuador does not have a dedicated bioaccess® country microsite as of this writing; ARCSA is named on the market-access hub.
RC&C vs bioaccess®
| Dimension | RC&C Consultores | bioaccess® |
|---|---|---|
| Public product | Holding de Registros + ARCSA dossiers + BPADT warehouse | LATAM Launch Subscription; own in-country entities |
| Multi-distributor pitch | Yes — explicit on the homepage | Yes — holder is not the distributor; registration is not leverage |
| Product mix | Devices plus foods, cosmetics, medicines, hygiene | Already FDA-cleared or CE-marked medical devices |
| Geography | Ecuador / ARCSA | 19 LATAM markets including ARCSA |
| Bundle / bridge | Country holding (no published all-in LATAM fee) | Gov fees + certified translations included; Trial-to-Market Bridge 20% |
The LATAM Launch Subscription from bioaccess® is a different product. bioaccess® registers already FDA-cleared (510(k)/PMA) or CE-marked devices and holds them through its own in-country entities — sanitary registration, registration holder / importer of record, certified Spanish or Portuguese translations (sworn where Brazil and Argentina require it), and government submission fees, inside one annual subscription per country and device family. Public coverage is described as 19 LATAM markets. The registration is held for the manufacturer’s benefit, with defined transfer provisions; it is not leverage. Clinical-trial clients of bioaccess® receive the published Trial-to-Market Bridge (20% off). Specific rates are under review; contact bioaccess® for a quote.
RC&C is a fair Ecuador holding shop when ARCSA is the only authority on the plan. bioaccess® is the operator when Ecuador is one market in a multi-country hold and the manufacturer wants the same transfer doctrine from Quito to Mexico City and São Paulo.
If the plan is one country and a homegrown titular is enough, hire the shop that actually publishes that job. If the plan is several LATAM labels under one holder who is not the distributor, start at bioaccess® market access or request a registration quote.
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