Regulatory & Compliance

How our products are made, and how they’re supplied.

NeoPep manufactures finished peptide products to GMP standards and supplies them to licensed clinics, pharmacies, telehealth providers and brand partners for dispensing within their own regulatory framework — not as consumer supplements. This page gives compliance and procurement reviewers the essentials, with full documentation available on request.

The essentials

What a reviewer needs to know.

1

Manufacturing standard

Finished products are made under GMP standards using a controlled cold-mix (<8°C) process, from formulation to individually pouched product.

2

Supply model

We supply B2B to licensed partners — clinics, pharmacies, telehealth and brands — who dispense within their own regulatory framework.

3

Documentation

Specifications, certificates of analysis (COA) and batch records are provided so your team can evaluate, register and dispense with confidence.

4

Your responsibility

Registration and market-specific compliance sit with the partner; requirements vary by territory. We provide the documentation to support it.

Content pending from NeoPep / regulatory counsel: the exact regulatory pathway per market (e.g. US 503A/503B compounding model, applicable classifications), any facility registrations or third-party certifications to cite, and approved wording for claims. Share these and we will finalise this page precisely — the structure above is drafted to that model but must be confirmed before launch.

Documentation available to partners

On request, under NDA where needed.

Product specificationsFormulation, dosage, format and storage details per product.

Certificates of analysis (COA)Batch-level quality and stability testing results.

Compliance summaryHow the supply and dispensing model works, in plain terms.

Reviewing NeoPep for your formulary or shelf?

We’ll send specifications, COAs and a plain-language compliance summary for your team.