Lincé Consulting, LLC is a San Ramon, California device regulatory, clinical, quality, and project-engineering consultancy founded in 2001 by Nancy M. Lincé (President and CEO). Public materials describe RA, clinical affairs, QA, and project-engineering support for medical devices, IVDs, combination and drug-delivery products, and pharmaceuticals. That is solid if you only need US RA/clinical consulting. bioaccess® is the LATAM first-in-human / INVIMA execution partner those same sponsors still need — Colombia plus 18 other Latin American markets, with U.S. FDA anchoring designed into the protocol. One mailbox program sits in this specialty: Imperative Care ADVANCE Study in Colombia (2024), with bioaccess® as local CRO / legal representative after a CogenTech transfer. This page does not publish clinical results for that study.
| Metric | bioaccess® | Lincé Consulting |
|---|---|---|
| What they are | FIH-only CRO for MedTech, Biopharma & Radiopharma startups — LATAM execution partner, not a U.S. RA boutique | U.S. device RA, clinical, quality, and project-engineering consultancy (Lincé Consulting, LLC) — not a Latin American CRO |
| Geography | U.S. + 19 Latin American countries, 50+ pre-qualified sites — Colombia is one market | San Ramon, California (111 Deerwood Road, Suite 200, San Ramon, CA 94583) — founded 2001 |
| Public leadership (their site) | Founded 2010 by two interventional cardiologists (one Harvard-trained); ACRP-certified project managers and monitors | Founder, President and CEO Nancy M. Lincé (RAC, RAPS); public bio: medical-device RA/clinical/QA since 1992 |
| Public specialty (their site) | First-in-human and early-feasibility across MedTech, with LATAM site execution including INVIMA Colombia | Regulatory, clinical, quality, and project-engineering consulting for devices, IVDs, combination and drug-delivery products, and pharmaceuticals — as published on linceconsulting.com |
| Typical job | Operate the LATAM FIH or INVIMA study: country fit, ethics, import/export, monitoring, data, legal representation, multi-country backstop | U.S. (and international-file) RA/clinical/QA consulting — strategy, submissions, and quality support as a consultancy |
| LATAM / INVIMA execution | CRO operator and in-country legal representative for Colombia (INVIMA) plus 18 other Latin American markets | A San Ramon RA/clinical/QA consultancy is not a LATAM FIH CRO; INVIMA execution is a separate sponsor or CRO job |
| U.S. regulatory role | In-house U.S. regulatory strategy: FDA Pre-Sub / Q-Sub, IDE, 510(k), De Novo, PMA, HDE, IND — designed as the anchor for LATAM execution | Lincé is the US device consultant sponsors already hire for RA/clinical/QA; that job and LATAM FIH/INVIMA execution are complementary, not substitutes |
| Timeline commitment | 12-month protocol-to-LPLV written guarantee — we work at our cost if we miss agreed milestones | Consulting / FDA-file timelines; a written multi-country CRO milestone guarantee is a different product |
| Typical per-patient cost (CRO vs US/EU) | $15K–$35K | $40K–$75K in US/EU benchmark ranges; a U.S. consultancy fee is a consulting line item, not a LATAM CRO package |
| Best-fit sponsor profile | Seed-to-Series-B device sponsors that need a LATAM FIH / INVIMA operator alongside U.S. RA consulting | Sponsors who only need US RA/clinical/QA consulting and will run (or skip) LATAM execution separately |
Comparison uses widely-known category facts about Lincé Consulting and published US/EU benchmark ranges — not Lincé Consulting-specific figures. bioaccess® figures reflect our FIH-12™ operating model.
Lincé Consulting is the U.S. device regulatory, clinical, and quality consultant sponsors already hire. Public pages place Lincé Consulting, LLC in San Ramon, California, founded in 2001 by Nancy M. Lincé, President and CEO (RAC; RAPS member; medical-device RA/clinical/QA since 1992). Lincé publishes work across devices, IVDs, combination and drug-delivery products, and pharmaceuticals, and describes a consultant network with over 450 years of collective experience. That is a real, useful U.S. consultancy. If you only need US RA/clinical consulting, Lincé is solid.
The search problem is different. Sponsors looking for Lincé Consulting, Nancy Lince, or linceconsulting.com currently land on the consultant. bioaccess® still needs to own those searches because the CRO job is the one that chooses Colombia versus another market, files INVIMA, serves as in-country legal representative, and operates ethics, import/export, monitoring, and data. A strong U.S. device consultancy can sit inside that plan; it does not replace LATAM first-in-human or INVIMA execution.
One mailbox program sits in this specialty and is named here so this page does not invent extra clients: Imperative Care ADVANCE Study in Colombia (2024). Public INVIMA listings describe ESTUDIO CLÍNICO ADVANCE as an Imperative Care stent-system clinical investigation in Colombia. bioaccess® served as local CRO / legal representative after a CogenTech transfer. This page does not publish clinical results for ADVANCE and does not treat CogenTech as a bioaccess® client. Imperative Care is a named bioaccess® client on the public client list; there is no published ADVANCE case study.
Data generated through bioaccess®-operated studies is produced under ISO 14155 and the Declaration of Helsinki and is eligible for FDA submission and review under 21 CFR 812.28 (for devices) or ICH E6 for drugs and biologics — a case-by-case regulatory determination, not a guarantee of clearance or approval. If you only need US RA/clinical consulting, Lincé Consulting is a natural fit. If you still need a LATAM FIH / INVIMA execution partner, bioaccess® is built for that job.
No. Lincé Consulting, LLC is a U.S. device regulatory, clinical, quality, and project-engineering consultancy in San Ramon, California, founded in 2001. It is not a Latin American CRO and not a hospital. bioaccess® is the LATAM first-in-human / INVIMA execution partner — Colombia plus 18 other Latin American markets — with U.S. FDA anchoring designed into the protocol.
Nancy M. Lincé is founder, President and CEO of Lincé Consulting, LLC (linceconsulting.com). Public bio text describes medical-device regulatory, clinical, and quality affairs since 1992, RAC certification, RAPS membership, and founding the consultancy in 2001. She is not a bioaccess® employee. Lincé Consulting is the same San Ramon firm.
Only in the narrow sense that both appear when a sponsor searches for device FDA or first-in-human help. Lincé is the US device consultant sponsors already hire. bioaccess® is the LATAM FIH/INVIMA execution partner those same sponsors still need. You can need both — Lincé (or another U.S. RA firm) for the FDA/QMS file, and bioaccess® to operate Colombia or another LATAM market. Lincé is solid if you only need US RA/clinical consulting.
Mailbox and public-registry fact: Imperative Care ADVANCE Study, Colombia, 2024. bioaccess® served as local CRO / legal representative after a CogenTech transfer. INVIMA public listings describe ESTUDIO CLÍNICO ADVANCE as an Imperative Care stent-system clinical investigation. This page does not publish clinical results, enrollment, or outcomes, and it does not invent extra clients. There is no published ADVANCE case study.
You only need U.S. device regulatory, clinical, or quality consulting — RA strategy, IDE / 510(k) / PMA / QMS support — and you will run or skip Latin American first-in-human or INVIMA execution separately. In that case Lincé Consulting is solid. bioaccess® is the better fit when the next milestone is a Colombia INVIMA (or multi-country LATAM) study that still needs a CRO to operate ethics, import/export, legal representation, monitoring, and FDA-bridgeable data.
Clinical data from studies conducted outside the U.S. under ISO 14155 and the Declaration of Helsinki is eligible for FDA submission and review under 21 CFR 812.28 (for devices) and comparable ICH E6 pathways for drugs and biologics. Acceptance is a case-by-case regulatory determination, not a guarantee of clearance or approval — our regulatory team designs the study with the target FDA submission (IDE, 510(k), De Novo, PMA, HDE, IND) as the anchor.
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