PRACTICAL GUIDE | 2026
First-in-Human for Biopharma in Latin America: Phase 1, Healthy Volunteers, and Bioanalytical Lab Selection
For biopharma FIH, the study is only half the question. The other half is who runs the assays — and whether regulators will accept the data.
By Julio G. Martinez-Clark
CEO, bioaccess®
Last verified: September 2026 | General information only—not legal or regulatory advice. Rules change frequently; confirm the strategy with qualified regulatory counsel.
Publishing package
Key entities, defined plainly. FIH means first-in-human — the first time a drug is given to people. Phase 1 is the first clinical stage, usually in healthy volunteers (HV). A bioanalytical lab measures drug concentrations (PK, pharmacokinetics), effects (PD, pharmacodynamics), immune responses (ADA, anti-drug antibodies), and biomarkers in study samples. GCP (Good Clinical Practice) governs clinical studies; GCLP (Good Clinical Laboratory Practice) applies GCP principles to labs that analyze clinical samples; GLP (Good Laboratory Practice) governs nonclinical studies. ICH M10 is the international guideline for bioanalytical method validation and study-sample analysis. LC-MS/MS (liquid chromatography–tandem mass spectrometry) and LBA (ligand-binding assay) are the two main analytical platforms. INVIMA is Colombia’s regulator, ANMAT is Argentina’s, and ANVISA is Brazil’s. B/BE means bioavailability/bioequivalence; ISO 17025 is a laboratory competence standard; SLA is a service-level agreement on turnaround time.
Why does bioanalytical lab selection start before first patient in?
In a device FIH, the data product is the clinical outcome. In a biopharma FIH, the data product is the assay result — PK curves, ADA incidence, biomarker movement. If the lab is wrong, the study is wrong, no matter how good the clinic is. Dose-escalation decisions run on bioanalytical turnaround: slow assays mean slow cohorts. Select the lab during synopsis development, not after the protocol is final.
What should a sponsor check when selecting a bioanalytical lab?
Six checks. Every one of them is verify-before-you-commit:
- GCP/GCLP compliance — not “GLP accreditation.” The lab analyzes clinical samples, so require GCP/GCLP compliance. GLP governs nonclinical studies; a lab with GLP experience for nonclinical support is a plus, but “GLP-accredited” is the wrong standard for a clinical bioanalytical lab.
- PK methods validated or transferred per ICH M10. Chromatographic (LC-MS/MS) or ligand-binding methods, as appropriate to the molecule. Method validation or a documented method transfer — not a handshake.
- ADA and biomarker assays validated fit-for-purpose. Immunogenicity (ADA) and biomarker assays must be validated under fit-for-purpose approaches consistent with FDA and EMA immunogenicity guidance. Be explicit about this: ICH M10 does NOT cover immunogenicity or biomarker assays. A lab that answers “we follow M10” for an ADA assay has not answered the question.
- Documented regulatory inspection history. Ask for inspection history and findings. There is no formal “prior data acceptance” register at INVIMA, ANVISA, or ANMAT — do not let anyone sell you a listing that does not exist. Prefer labs that sit inside a regulator-authorized Phase 1 center (for example, under ANMAT’s post-7516/2025 FIH-center authorization framework).
- Turnaround SLA fast enough for dose escalation. Dose-escalation committees decide on data. Get the turnaround commitment in writing, and keep a central-lab fallback (US or EU) for any method not locally validated.
- Lock the assay format, matrices, and biomarker panel early. In the synopsis — not during study startup. Late changes to the assay panel are one of the most common preventable causes of FIH delay.
| Criterion | What good looks like | Red flag |
|---|---|---|
| Compliance standard | GCP/GCLP-compliant lab; GLP experience for nonclinical support a plus | “GLP-accredited” presented as the clinical-lab standard |
| PK validation | ICH M10-validated or transferred methods (LC-MS/MS or LBA) | No validation package; verbal assurance only |
| ADA / biomarkers | Fit-for-purpose validation per FDA/EMA immunogenicity guidance | “We follow ICH M10” for an ADA assay |
| Regulatory track record | Documented inspection history; lab inside a regulator-authorized Phase 1 center | Claims of a formal “accepted lab” register that does not exist |
| Turnaround | Written SLA supporting dose-escalation cadence; central-lab fallback | No SLA; no fallback plan |
| Assay lock | Format, matrices, and panel fixed in the synopsis | Assay decisions drifting into startup |
Does INVIMA B/BE certification or ISO 17025 settle the question?
No — and this is a common expensive misunderstanding. INVIMA’s bioavailability/bioequivalence (B/BE) certification is a BE-only scheme built for generic-drug registration. For an FIH program, treat it as an optional quality signal about a lab’s general discipline — never as an FIH requirement. A lab without B/BE certification is not disqualified from FIH work, and a lab with it is not automatically qualified.
ISO 17025 works the same way: a genuine differentiator in laboratory competence, but not a requirement for FIH bioanalysis. Use it as a tiebreaker between two otherwise equal labs, not as a gate.
Where do healthy-volunteer Phase 1 units fit in Latin America?
Argentina and Chile make a strong primary/backup healthy-volunteer pairing: established Phase 1 unit infrastructure, experienced investigators, and — in Argentina — a defined Phase I review clock of 35 technical plus 10 administrative business days (about 45 total) under ANMAT Disposición 7516/2025, Annex III. Mexico and Brazil have deep clinical infrastructure, but their healthy-volunteer Phase 1 capacity is less established than Argentina’s and Chile’s — factor that into country selection for a healthy-volunteer study, not just the regulatory clock.
Frequently asked questions
Is GLP accreditation required for the bioanalytical lab?
No. GLP governs nonclinical studies. For a lab analyzing clinical FIH samples, require GCP/GCLP compliance. GLP experience supporting nonclinical work is a bonus, not the standard.
Does ICH M10 cover immunogenicity and biomarker assays?
No. ICH M10 covers chromatographic and ligand-binding PK assays. ADA and biomarker assays need fit-for-purpose validation consistent with FDA and EMA immunogenicity guidance.
Can I use my US or EU central lab instead of a local one?
Yes — keep a central-lab fallback for any method not locally validated. Build it into the plan and the budget from the start, not as an emergency fix.
Does an INVIMA B/BE certificate qualify a lab for FIH bioanalysis?
It is an optional quality signal only. B/BE certification is a generic-registration scheme, not an FIH requirement.
Is there an official list of regulator-accepted bioanalytical labs?
No. There is no formal prior-acceptance register at INVIMA, ANVISA, or ANMAT. Evaluate documented inspection history instead.
How fast can a Phase 1 start in Argentina?
ANMAT’s Phase I clock is 35 technical plus 10 administrative business days — about 45 total — under Disposición 7516/2025, Annex III.
That discipline — lock the assays early, select the lab on documented evidence, and pair your healthy-volunteer units across countries — is what First-in-Human for Biopharma in Latin America: Phase 1, Healthy Volunteers, and Bioanalytical Lab Selection is really about. The lab is part of the study design, not a procurement line item.
References
- ICH M10 — Bioanalytical Method Validation and Study Sample Analysis.
- FDA and EMA immunogenicity/ADA assay guidance (fit-for-purpose validation).
- ANMAT Disposición 7516/2025, Annex III (Phase I review clock: 35 technical + 10 administrative business days).
- OECD Principles of GLP and GCLP guidance documents (scope: nonclinical vs. clinical-sample analysis).
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