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 partner those same sponsors still need: drug, biologic, and vaccine trials in Colombia, and a medical device clinical trial in Panama, El Salvador, Chile, Costa Rica, the Dominican Republic, or Colombia, with U.S. FDA anchoring designed into the protocol. bioaccess® runs first-in-human studies in Colombia now, devices included.
| Metric | bioaccess® | Lincé Consulting |
|---|---|---|
| What they are | FIH-only CRO for MedTech and Biopharma startups, with radiopharma trial support — 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, 100+ 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 — if we miss it for reasons within our control, we credit 100% of our project-management and monitoring fees until LPLV | Consulting / FDA-file timelines; a written multi-country CRO milestone guarantee is a different product |
| Typical per-patient cost (CRO vs the US) | See sample budget | No published US comparison; 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 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 chooses the country, files the local authority, serves as in-country legal representative, and operates ethics, import/export, monitoring, and data. A device study is led from Panama, El Salvador, Chile, Costa Rica, the Dominican Republic, or Colombia. bioaccess® runs first-in-human studies in Colombia now, devices included. A strong U.S. device consultancy can sit inside that plan; it does not replace that execution.
We do not name sponsors or publish clinical results. bioaccess® runs first-in-human studies in Colombia now, devices included, and acts as local CRO and legal representative for device studies.
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® leads a medical device clinical trial from Panama, El Salvador, Chile, Costa Rica, the Dominican Republic, or Colombia. bioaccess® runs first-in-human studies in Colombia now, devices included, 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 CRO those same sponsors still need for a device study in Panama, El Salvador, Chile, Costa Rica, the Dominican Republic, or Colombia, and for a drug, biologic, or vaccine trial in Colombia. You can need both. Lincé is solid if you only need US RA/clinical consulting.
Yes. bioaccess® has a Colombian legal entity and office and can act as local CRO and legal representative for a device study in Colombia. We do not name sponsors or publish clinical results.
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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