In Peru the sanitary-registration holder must be a DIGEMID-authorized pharmaceutical establishment (droguería) with a BPA warehouse and a químico farmacéutico as director técnico. “Independent holder” here means a droguería that will file and import without locking the manufacturer to its own commercial catalog. Pharma Consulting publishes that product at pharmaconsulting.pe/es/holder-de-registro-sanitario-en-peru/ (indexed holder URL as of 23 August 2026; the page is often Cloudflare-walled to automated fetch). This article uses only that public offer, then contrasts it with multi-country market access from bioaccess®.
What Pharma Consulting publishes
Public positioning, from the indexed holder page and on-SERP extract: they act as holder de registro sanitario in Peru through their own DIGEMID droguería, warehouse, and full-time director técnico. They file to DIGEMID. Site navigation lists devices, IVD, and prostheses among the product types they address. That is a one-country droguería-titular, not a published multi-country holder.
Peru’s current rule set (Decreto Supremo N° 001-2024-SA, as summarized on the bioaccess® IOR guide) permits an independent Peru Registration Holder; additional droguerías can obtain their own CRS. So the manufacturer can keep a neutral titular and still authorize more than one import path — if the first titular is not also the exclusive seller. Giving the droguería-titular role to the first commercial partner recreates the leverage problem under a different noun.
bioaccess® manages DIGEMID registration and market entry as part of its market-access service (Peru is named on the market-access hub; there is not a separate /market-access/peru microsite as of this writing). Peru pricing: a one-time registration fee of $4,250 (Class I), $6,500 (Class II) or $10,500 (Class III/IV), then an annual holder fee of $4,200 from year 2 (rate card). The holder is bioaccess®’s in-country structure, not the distributor.
Pharma Consulting vs bioaccess®
| Dimension | Pharma Consulting (Peru) | bioaccess® |
|---|---|---|
| Public product | DIGEMID droguería titular + warehouse + DT | Holder/IOR under contract (own entity in Colombia; local partner elsewhere) |
| Who must hold | A licensed droguería (their establishment) | Same legal constraint; bioaccess® supplies the in-country establishment |
| Devices | Devices / IVD / prostheses listed in nav | Already FDA-cleared or CE-marked devices |
| Geography | Peru | Published pricing in Mexico, Colombia, Brazil, Peru and Argentina, including Peru (DIGEMID); other markets quoted case by case |
| Bundle / bridge | Country holder (no published all-in LATAM fee or FIH bridge) | Certified translations in-house; Two-part: one-time registration fee per country by class, then an annual holder fee from year 2 (rate card) |
bioaccess® market access is a different product. bioaccess® registers already FDA-cleared (510(k)/PMA) or CE-marked devices and holds them under contract — sanitary registration, registration holder / importer of record (in Colombia through its own Colombian entity; elsewhere with its local partner), and certified Spanish or Portuguese translations (sworn where Brazil and Argentina require it). Pricing is published for Mexico, Colombia, Brazil, Peru and Argentina; Chile and other markets are quoted case by case. The registration is held for the manufacturer’s benefit, with defined transfer provisions; it is not leverage. 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).
Pharma Consulting is a fair Peru droguería titular. bioaccess® is the operator when Peru is one market next to COFEPRIS, ANVISA, INVIMA, or ANMAT, and the manufacturer wants one holder doctrine in all of them.
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.