# Services: development, legal manufacturing, white & private label | INOPREX

> Service overview: product development, legal manufacturing (QMS under ISO 13485:2016 in progress), white label from 10,000 units per SKU, private label development and regulatory consulting — from a single source.

Quelle: https://inoporex.de/en/leistungen/

---

## Everything from one source — from formulation to market access

INOPREX provides development, legal manufacturing and regulatory consulting for medical devices, cosmetics and food supplements. One contractual partner, one contact, full regulatory responsibility.

INOPREX is a development and manufacturing partner for medical devices, cosmetic products and food supplements. The service portfolio covers product development, legal manufacturing (QMS under ISO 13485:2016 in progress, certification initiated), white label from 10,000 units per SKU, private label as an exclusive new development and regulatory consulting for audits, QM systems and claims.

- **Product development** — Conception, formulation, regulatory classification upfront, claim strategy, sample production and scale-up to series. (https://inoporex.de/en/leistungen/produktentwicklung/)
- **Legal manufacturing (ISO 13485)** — Legal manufacturer for medical devices under EU MDR, class I to IIb — QMS under ISO 13485:2016 in progress, technical documentation, EUDAMED, vigilance, PMS. (https://inoporex.de/en/leistungen/legalhersteller-iso-13485/)
- **Private label** — Exclusive new development to your briefing. Formulation and IP stay with the client, MOQ project-dependent. (https://inoporex.de/en/leistungen/private-label/)
- **White label** — Established, documented formulations — MOQ from 10,000 units per SKU, short time-to-market. Catalogue under NDA. (https://inoporex.de/en/leistungen/white-label/)
- **Regulatory consulting** — Audit preparation ISO 13485 and ISO 22716, gap analyses, claim review, training, interim PRRC. (https://inoporex.de/en/leistungen/regulatory-consulting/)

## Which service fits your project?

In an initial consultation we clarify which modules your project needs — development, legal manufacturing, consulting or a combination.