About CertikLabs
CertikLabs is a PhD-led analytical chemistry laboratory accredited to ISO/IEC 17025:2017, operated under a cGMP-aligned quality system, and registered with CLIA and the DEA. We exist to do one thing exceptionally well: tell buyers, brands, and regulators what is actually inside a peptide vial — and prove it on a public, tamper-evident record.
184,000+
Batches verified
99.97%
On-time release rate
<2%
Quantitative CV
0
Findings on last ISO audit
01 · Mission
The research-peptide market moves billions of dollars a year on the strength of a PDF emailed from a vendor's inbox — a document that is trivially edited, frequently fabricated, and almost never re-verified after purchase. Buyers are asked to take quality on faith. Honest brands compete with dishonest ones on equal footing. Regulators have no audit trail.
CertikLabs replaces that PDF with something a buyer, a brand, and a regulator can all check independently: a public verification page tied to a specific physical batch, backed by a sealed Certificate of Analysis whose cryptographic fingerprint is anchored on a public blockchain at the moment of issuance. The report cannot be edited after the fact. The lab cannot quietly re-issue it. The brand cannot host a different version on its own server.
Behind that simple promise sits a serious laboratory: validated USP <1225> / ICH Q2(R1) methods, NIST-traceable reference standards, redundant orthogonal instrumentation, and a quality manual audited annually by A2LA. We built CertikLabs because the peptide industry deserves the same standard of evidence that small-molecule pharmaceuticals have taken for granted for forty years.
02 · Principles
Four operating principles that govern every sample that enters our chain-of-custody.
Every report we issue is public by default. The raw chromatograms, the method validation packet, and the SHA-256 anchor record are all one click away from the verification URL — for anyone, forever.
We do not manufacture, distribute, or resell peptides. We hold no equity in any brand we test. Our only product is the truth printed on the report — and we will publish out-of-spec results with the same diligence as passing ones.
Every assay maps to a published SOP, a validated method, and a calibrated reference standard traceable to NIST or USP. Bring your own auditor — we have already prepared the packet.
We invest in the instruments most independent labs cannot justify: high-resolution Orbitrap MS, charged-aerosol detection, and orthogonal confirmatory methods. If two techniques disagree, we report both.
03 · Accreditations
Every credential below is verifiable with the issuing body. Where applicable, the certificate number is printed on the bottom of the linked PDF and on every Certificate of Analysis we release.
A2LA Cert. # 6841.01
Accredited for the competence of testing laboratories — peptide HPLC purity, LC-MS identity, and quantitative concentration assays. Annual surveillance audit; full re-assessment every two years.
Quality Manual QM-04 · Rev. 9
Documented Quality Management System mirroring U.S. FDA Current Good Manufacturing Practice. Validated methods, calibrated reference standards, and chain-of-custody for every sample.
CLIA #45D2204881
Federally registered for high-complexity analytical testing. Personnel and proficiency-testing requirements verified by CMS biennially.
DEA #RC0418277
Authorized for handling of Schedule III–V reference materials, enabling rigorous comparison testing against pharmacopeial standards.
Per-assay validation packets on file
Every method we publish is validated for specificity, linearity, accuracy, precision, LOD/LOQ, and robustness — and that validation packet is publicly linkable from the verification page.
Open-verifiable, immutable
Every Certificate of Analysis is hashed and anchored to a public blockchain at issuance. Anyone — buyer, regulator, or competitor — can independently verify the document was not altered.
04 · The team
CertikLabs is staffed by analytical chemists, biochemists, and quality professionals from the same programs that train pharmaceutical industry leadership. Four of our six senior staff hold PhDs; every released report is reviewed by at least two qualified analysts.
Dr. Elena Marchetti, PhD
Co-founder & Scientific Director
PhD Analytical Chemistry, ETH Zürich
Elena spent 16 years inside pharmaceutical method development at Lonza and Bachem before co-founding CertikLabs, where she owns scientific direction across every assay we publish. She is lead author on three USP monograph revisions for therapeutic peptides, sits on the AAPS Therapeutic Peptide focus group, and personally signs off on every new method validation packet before it enters production.
Dr. Marcus Chen, PhD
Co-founder & Head of Operations
PhD Biochemistry, Johns Hopkins
Marcus was Director of QC at a top-five U.S. contract peptide manufacturer for nearly a decade before co-founding CertikLabs. He architected our chain-of-custody, LIMS, and on-chain anchoring stack from first principles, and is the operational owner of every batch that moves through the lab — from intake seal to anchored Certificate of Analysis.
Dr. Priya Nair, PhD
Director of Mass Spectrometry
PhD Bioanalytical Chemistry, Purdue University
Priya leads our high-resolution LC-MS group, including two Orbitrap Exploris 240 instruments dedicated to identity confirmation and impurity profiling. Twelve years of bioanalytical work across GLP-1 analogs, growth-hormone secretagogues, and BPC/TB families have produced two issued patents and a half-dozen peer-reviewed publications on peptide-related substances.
Dr. Samuel Okafor, PharmD, RPh
Quality Assurance Officer
PharmD, University of Michigan · ASQ Certified Quality Auditor
Samuel owns the ISO/IEC 17025 Quality Manual, the internal audit calendar, and the out-of-spec investigation protocol. A licensed pharmacist and ASQ-certified auditor, he is the final signatory on every released report and the lab's primary point of contact for state boards of pharmacy and accrediting bodies.
Hannah Reyes, MS
Lead HPLC Analyst
MS Analytical Chemistry, UC Davis
Hannah runs CertikLabs' twelve-instrument HPLC bench and authored the validated purity methods now in production for semaglutide, tirzepatide, retatrutide, BPC-157, and TB-500. Before joining the lab she spent six years in stability and release testing at a CDMO supporting commercial-stage injectables.
James Whitaker
Director of Compliance & Chain-of-Custody
B.S. Forensic Science · Former FDA OCI Investigator
James spent twelve years as a Special Agent with FDA's Office of Criminal Investigations before joining CertikLabs to design our tamper-evident sample-intake workflow. He owns regulator liaison work — DEA, state boards of pharmacy, and FDA inquiries — and trains every new analyst on evidence-grade documentation practices.
05 · Our commitment
Every Certificate of Analysis is signed by two qualified analysts and one Quality Assurance Officer.
Every report is hashed (SHA-256) and anchored on a public blockchain within minutes of release.
Out-of-spec results are reported to the brand and made public on the verification page — never quietly suppressed.
Brands cannot pay to have a failed batch re-tested without a documented root-cause investigation on file.
Retention samples are kept under controlled conditions for a minimum of 24 months for any third-party re-test.
Our pricing, methods, and accreditation packets are public — no NDA required.
Buyers can verify any CertikLabs report in seconds. Brands can be on the verification platform in under a week.
Related
/api
REST endpoints, webhooks, and SDKs for partners integrating CertikLabs verification into their systems.
/batches
Browse recent CertikLabs batch verifications. Every batch resolves to a permanent, public verification page with product, vendor, purity, and status.
/capabilities
Standardized peptide assays: HPLC purity to 0.01%, LC-MS identity (±0.1 Da), quantitative concentration (CV<2%), endotoxin (LAL), and custom methods.