EM
Dr. Elena Marchetti, PhD
Co-founder & Scientific Director
PhD Analytical Chemistry, ETH Zürich
16 years in pharmaceutical method development at Lonza and Bachem. Lead author on three USP monograph revisions for therapeutic peptides.
About CertikLabs
An independent lab built for an industry that finally needs one.
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
Make trust measurable.
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
How we do it, every day.
Four operating principles that govern every sample that enters our chain-of-custody.
Radical Transparency
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.
Independence Above All
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.
Methodology You Can Audit
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.
Science Without Compromise
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
Certifications, licenses, and standards.
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.
ISO/IEC 17025:2017
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.
cGMP-Aligned (21 CFR Part 211)
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 Certificate of Compliance
CLIA #45D2204881
Federally registered for high-complexity analytical testing. Personnel and proficiency-testing requirements verified by CMS biennially.
DEA Analytical License
DEA #RC0418277
Authorized for handling of Schedule III–V reference materials, enabling rigorous comparison testing against pharmacopeial standards.
USP <1225> & ICH Q2(R1) Method Validation
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.
Anchored Reporting (SHA-256 / Public Ledger)
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
Scientists, not salespeople.
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.
MC
Dr. Marcus Chen, PhD
Co-founder & Head of Operations
PhD Biochemistry, Johns Hopkins
Former Director of QC at a top-five contract manufacturer. Built CertikLabs' chain-of-custody and on-chain anchoring stack from first principles.
PN
Dr. Priya Nair, PhD
Director of Mass Spectrometry
PhD Bioanalytical Chemistry, Purdue University
12 years of high-resolution LC-MS experience across GLP-1 analogs and growth-hormone secretagogues. Holds two patents in peptide impurity profiling.
SO
Dr. Samuel Okafor, PharmD, RPh
Quality Assurance Officer
PharmD, University of Michigan · ASQ Certified Quality Auditor
Owns the ISO 17025 Quality Manual, internal audit calendar, and out-of-spec investigation protocol. Final signatory on every released report.
HR
Hannah Reyes, MS
Lead HPLC Analyst
MS Analytical Chemistry, UC Davis
Runs the 12-instrument HPLC bench. Personally validated CertikLabs' purity methods for semaglutide, tirzepatide, BPC-157, and TB-500.
JW
James Whitaker
Director of Compliance & Chain-of-Custody
B.S. Forensic Science · Former FDA OCI Investigator
Designs the tamper-evident sample-intake workflow and liaisons with state boards of pharmacy and FDA inquiries.
05 · Our commitment
The commitments we make to every batch.
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.
Verify a batch — or put your brand on the public record.
Buyers can verify any CertikLabs report in seconds. Brands can be on the verification platform in under a week.
Related
Continue reading
/for-business
For Brands — Verification that lifts conversion
How peptide brands use CertikLabs to win buyer confidence and outperform on conversion, AOV, and repeat rate.
/proof
Proof of Authenticity — Every report, anchored on-chain
Every CertikLabs report is hashed (SHA-256) and anchored to a public blockchain at issuance — tamper-evident, third-party-verifiable, and permanent.
/capabilities
Lab Capabilities — HPLC, LC-MS, Concentration
Standardized peptide assays: HPLC purity to 0.01%, LC-MS identity (±0.1 Da), quantitative concentration (CV<2%), endotoxin (LAL), and custom methods.