Compliance Infrastructure for the Peptide Industry.
The only platform that combines GMP-verified API sourcing, real-time track & trace, and expert 503A/503B consulting—giving compounding pharmacies, clinics, and distributors the compliance infrastructure to source, operate, and scale with full regulatory confidence.
COMPLIANCE STANDARDS WE ALIGN WITH
Certification verification available upon request. Contact us for current documentation.
EXAMPLE INTEGRATIONS
Illustrative partners — not verified integrations
Source. Comply. Scale.
GMP-verified API sourcing, compliance-ready white-label product lines, and expert 503A/503B consulting—oriGENapi is the end-to-end compliance and sourcing platform for the peptide industry.
Pharmaceutical-Grade APIs
Single-source, pure peptide APIs sourced from GMP-certified manufacturers. Every ingredient comes with full Certificates of Analysis, batch documentation, and complete traceability.
White-Label Finished Products
Launch your own branded peptide and supplement product lines. We handle formulation, manufacturing, packaging, and compliance—you build the brand your patients and customers trust.
Compliance Suite
From compliant marketing strategies to mock FDA pre-inspections and 503A/503B setup consulting—oriGENapi gives your operation the compliance infrastructure to operate with full regulatory confidence.
Every Compliance Need. One Platform.
From FDA warning letter response to 503B CGMP setup—oriGENapi combines compliance consulting, auditing, and marketing guidance with ERP and real-time track & trace infrastructure to back it all up.
Compliant Marketing
Navigate the peptide marketing minefield with confidence. We ensure your advertising, social media, and patient communications stay within FDA 21 CFR 202 and FTC substantiation bounds—protecting your practice from costly warning letters.
Compliance Auditing
Proactively close compliance gaps before the FDA does. Our team conducts mock pre-inspections, COA integrity reviews, DSCSA track & trace audits, and SOP gap analyses—delivering written remediation reports with clear action plans.
503A & 503B Consulting
Expert guidance for compounding pharmacies and outsourcing facilities—from 503A state board applications and PCAB accreditation prep to 503B FDA registration, CGMP quality system development, and warning letter remediation.
POWERED BY YOUR DATA
Your ERP & Track & Trace Already Make You Audit-Ready.
Clients on the oriGENapi platform already generate the batch records, COA documentation, and chain-of-custody logs that regulators demand. Our consultants turn that existing data into a compliance program—transforming a multi-week audit into a multi-day one.
FTC-Safe Quiz Funnels That Sell Supplements for You.
We build custom branded quiz funnels that are structured from the ground up within FDA and FTC substantiation guidelines. Customers take a health quiz, get compliant AI-matched recommendations, and buy — all within your brand experience, with zero liability exposure.
Perfect For
Gamified Quiz Builder
Interactive, multi-step health quizzes that feel like a game — not a form. Keeps customers engaged and reduces drop-off.
AI Product Matching
Our engine maps every quiz answer to your specific product catalog and surfaces the highest-fit recommendation automatically.
Direct-to-Cart
Recommended products are served with a one-click 'Add to Cart' — shortening the path from discovery to purchase.
Conversion Analytics
See exactly which questions drive purchases. A/B test quiz flows and optimize your funnel with real conversion data.
White-Label Embed
Fully branded with your colors, logo, and fonts. Embeds on Shopify, WooCommerce, or any custom site via widget or API.
FTC-Compliant Claims
Every quiz recommendation is structured within FTC substantiation bounds and FDA 21 CFR 202 guidelines — no unapproved drug claims, no liability exposure.
How It Works
Customer takes your branded 5-step health quiz
AI engine matches answers to products — within FTC substantiation bounds
Compliant recommendation delivered: structure/function claims only, no disease claims
One click to cart — you make the sale, compliantly
All quiz copy reviewed for FDA 21 CFR 202 compliance and FTC substantiation requirements before launch.
Built-In Compliance Review
Every quiz we build undergoes a full compliant marketing review before launch — checking for unapproved drug claims, FTC substantiation gaps, and off-label promotion risks specific to peptides and supplements.
In Development — Practitioner Tools
Personalization tools your practice will deploy for clients — genomic testing, AI protocol matching, and branded quizzes.
Help Your Clients Find Their Perfect Protocol.
We're building a suite of practitioner-deployed tools — branded health quizzes, AI-driven matching, and genomic integration — that your practice offers to clients under your own brand.
Client Health Quizzes
Deploy science-backed wellness quizzes under your brand — your clients complete them, you get the insights.
Genomic Integration
Your clients upload WGS or PGX results for DNA-driven protocol matching tied to your product catalog.
AI Protocol Matching
Our engine recommends the right peptides and supplements from your line — personalized per client.
Practice Analytics
Track client outcomes and receive data-driven protocol updates that keep your product recommendations current.
Offer Your Clients DNA-Level Personalization.
Whole Genome Sequencing (WGS) and Pharmacogenomics (PGX) testing — offered through your practice — match each client's protocol to their unique genetic blueprint.
Whole Genome Sequencing (WGS)
Each client's full DNA sequence analyzed for nutrient metabolism, peptide response, and supplement optimization—results tied to your product catalog.
Pharmacogenomics (PGX)
Targeted analysis of how a client's genes affect their response to pharmaceutical compounds, peptides, and supplements.
HIPAA Compliant & Secure
Enterprise-grade security with end-to-end encryption. Your clients own their genomic data—always.
FROM TEST TO PROTOCOL
Join the waitlist at assessment-gate to be notified at launch.
Source. Audit. Comply. The Complete Peptide Compliance Platform.
oriGENapi is the only platform that combines GMP-verified API sourcing with expert 503A/503B consulting, compliance auditing, and compliant marketing guidance—backed by ERP and real-time track & trace infrastructure.
GMP-Verified API Sourcing
Single-source, pure peptide APIs from GMP-certified manufacturers. Every ingredient comes with full Certificates of Analysis, batch documentation, and complete chain-of-custody traceability.
White-Label Finished Products
Launch your own branded peptide and supplement product lines with full regulatory compliance documentation baked in—your brand built on a compliant foundation from day one.
Compliance Auditing
Proactively close compliance gaps before the FDA does. Our team conducts mock pre-inspections, COA integrity audits, SOP gap analyses, and DSCSA track & trace reviews with written remediation reports.
503A & 503B Consulting
Expert guidance for compounding pharmacies and outsourcing facilities—from 503A state board applications and PCAB accreditation prep to 503B FDA registration and CGMP quality system development.
Compliant Marketing
Navigate the peptide marketing minefield with confidence. We ensure your advertising, social media, and patient communications stay within FDA 21 CFR 202 and FTC substantiation bounds—protecting your practice.
Track & Trace Infrastructure
Built-in ERP and real-time track & trace systems produce the batch records, COA documentation, and chain-of-custody logs that regulators demand—turning audits from multi-week events into multi-day ones.
Built for Real Practitioners & Brands
The following are illustrative scenarios representing the types of outcomes our platform is designed to enable. Names and companies are fictional.
* These are example scenarios for illustrative purposes only and do not represent verified customer testimonials.
“We launched three private-label peptide lines through oriGENapi in under 90 days. The supplier qualification, COA verification, and custom packaging coordination—all in one platform—saved us months of work.”
“We went from sourcing generic peptides to offering our own white-label wellness line. oriGENapi connected us with GMP manufacturers who handle custom formulation and branded packaging. Our clients love it.”
“As a health food distributor, having verified COAs and GMP documentation for every peptide batch gives our retail partners the confidence they need. oriGENapi made compliance effortless.”
“I went from promoting other brands to launching my own private-label peptide line in under 60 days. oriGENapi handled the sourcing, COAs, and packaging—I just focused on my brand and audience.”
“Our practice needed pharmaceutical-grade peptides with complete regulatory documentation. oriGENapi gave us direct access to GMP-certified suppliers with audit trails our compliance team loves.”
Who We Serve
Med spas, supplement distributors, e-commerce brands, practitioners, and creators — all in one platform.
Compliance-Ready for Every Peptide Business.
From 503A compounding pharmacies navigating state board requirements to distribution enterprises managing DSCSA compliance—oriGENapi provides the sourcing, consulting, and infrastructure every segment of the peptide industry needs.
Source. Audit. Comply. Scale.
oriGENapi integrates GMP-verified sourcing with compliance auditing and 503A/503B consulting—a single infrastructure layer that replaces fragmented vendors and reactive compliance with one proactive, unified platform.
Source & Verify
Browse our network of GMP-certified peptide API suppliers. Every API includes automated COA verification, batch documentation, and full chain-of-custody traceability—no manual supplier vetting required.
Audit & Certify
Our compliance team conducts gap analysis, mock FDA pre-inspections, and COA integrity reviews—ensuring your operation meets 503A/503B, GMP, and DSCSA standards before regulators show up.
Consult & Scale
From 503A pharmacy setup to 503B CGMP implementation, our consultants guide your operation through FDA registration, quality system development, warning letter remediation, and ongoing compliance programs.
† Figures marked with † represent projected platform capacity and targets based on market analysis. Actual verified metrics will be published upon platform launch.
Source. Comply. Scale. All in One Platform.
Whether you need GMP-verified peptide APIs, expert 503A/503B consulting, a mock FDA pre-inspection, or compliant marketing guidance—oriGENapi is the compliance infrastructure your peptide operation needs.