SPI Americas shows up when manufacturers search for a Latin American registration holder or sanitary-registration partner. This article uses only what SPI Americas publishes on its own site (spiamericas.com/asuntos-regulatorios), then compares it with multi-country market access from bioaccess®. It is a practitioner comparison, not a teardown.
What SPI Americas publishes
SPI Americas is a Colombia-based firm with regulatory, IP and corporate practices. Its regulatory affairs page sells "hosting" ("parqueadero regulatorio"), where SPI becomes the party responsible before the authority, plus INVIMA dossiers, CCAA, semantic standard and tecnovigilancia. It works across several Latin American countries from Colombia, and the INVIMA work is the deepest.
SPI Americas vs bioaccess®
| Dimension | SPI Americas | bioaccess® |
|---|---|---|
| Public product | Regulatory hosting ("parqueadero regulatorio") + INVIMA dossiers, CCAA, tecnovigilancia | Registration, in-country holder, certified translations, tecnovigilancia as holder (import shipments quoted separately) |
| Geography | Colombia-led, multi-country Latin America | Published pricing in Mexico, Colombia, Brazil, Peru and Argentina; other markets quoted case by case |
| Public pricing | None published | Two-part: one-time registration fee per country by class, then an annual holder fee from year 2 (rate card) |
| Holder vs distributor | See the provider’s own terms | Holder under contract (own Colombian entity in Colombia; local partner elsewhere), with defined transfer provisions; the registration is never leverage |
| Bridge from a clinical trial | None published | Same firm can run the LATAM clinical trial and then hold the commercial registration |
Where each one fits
If Colombia is the anchor market and you also want IP or corporate counsel from the same firm, SPI Americas is a sensible pick.
bioaccess® market access is a different product. bioaccess® registers already FDA-cleared or CE-marked devices and acts as their registration holder under contract (in Colombia through its own Colombian entity; elsewhere with its local partner) across Latin American markets, including COFEPRIS, ANVISA, INVIMA, ANMAT, ISP and DIGEMID. Pricing is two-part pricing: a one-time registration fee per country by device class, then a lower annual holder fee from year 2 (published for Mexico, Colombia, Brazil, Peru and Argentina on the rate card). Importer-of-record shipments are quoted separately. The registration is held for the manufacturer’s benefit, with defined transfer provisions if you ever change partners or set up your own entity.
One country and one local partner is enough? Hire the firm that publishes that job. Several LATAM labels under one holder who is not your distributor? Start at bioaccess® market access, read the LATAM importer of record guide, try the market-access calculator, or request a registration quote.
Competitor facts from the SPI Americas public pages linked above, reviewed for bioaccess® competitive research (Aug–Oct 2026). Claims are theirs. No invented clients, prices or contacts.