INOPREX HealthTec
Your brand. Our development.
INOPREX is a development and manufacturing partner for medical devices, cosmetic products and food supplements — with regulatory responsibility from a single source. White label from 10,000 units per SKU, private label as an exclusive new development.
Three product categories — one partner
INOPREX develops, manufactures and takes on regulatory responsibility — in the role that fits your project. For medical devices we act as the legal manufacturer under EU MDR. For cosmetics and food supplements we either take on the role of the responsible person or the person placing the product on the market, or we manage development and production while your brand remains the market operator. Production runs together with leading contract manufacturers and fillers in the EU.
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Medical devices
Non-active medical devices class I, IIa and IIb under EU MDR: nasal sprays, eye drops, wound care, dermatology, gastrointestinal, intimate health and more.
Class I–IIb · EU MDR
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Cosmetics
Cosmetic products under Regulation (EC) No 1223/2009: face, body, hair, sun protection, baby, men, intimate care — white label from 10,000 units per SKU.
Reg. (EC) 1223/2009
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Food supplements
Supplements under LFGB, Regulation (EC) No 1169/2011 and NemV: capsules, tablets, powders, sticks, shots, gummies — claims under the Health Claims Regulation.
LFGB · NemV
White label or private label?
Two routes to a product: white label uses an existing, documented INOPREX formulation (MOQ from 10,000 units per SKU, short time-to-market). Private label develops an exclusive formulation to your briefing — formulation and IP stay with the client, the MOQ is project-dependent.
| Criterion | White label | Private label |
|---|---|---|
| Formulation | established INOPREX formulation | new development to briefing |
| Exclusivity | not exclusive | exclusive to the client |
| IP rights | with INOPREX | with the client |
| MOQ | from 10,000 units per SKU | project-dependent |
| Time-to-market | short | longer, depending on scope |
| Documentation | available | created within the project |
| Customisable | packaging, design, fragrance, fill volume | fully |
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From idea to series production — in six steps
- 01
Briefing & feasibility
We assess your product idea, intended claims, dosage form and regulatory framework — and tell you clearly what is feasible.
- 02
Regulatory classification & claims
Medical device, cosmetic or food supplement? We fix the classification before formulation and communication are developed.
- 03
Formulation & samples
Formulation development, stability testing and sample production — with qualified contract manufacturers and fillers in the EU.
- 04
Technical documentation
Technical documentation, PIF, labelling and claims are prepared completely and audit-ready — according to the applicable standards of each category.
- 05
Production & release
Series production in the qualified EU network, batch-related quality release and traceability from a single source.
- 06
Market access & post-market
Registration, EUDAMED/CPNP, vigilance and post-market surveillance accompany your product beyond market entry.
Who we work for
- Brand owners and D2C brands
- Retail and trade
- Drugstore and pharmacy brands
- Distributors
- Bulk consumers and public contractors
- Startups without their own regulatory department
- international manufacturers needing EU market access
Ready for the first step?
Tell us about your project via the contact form: category, dosage form, volume and target market are enough to start. We will respond within two working days with an initial assessment.