# Product development: formulation, claims, samples to series | INOPREX

> Product development at INOPREX: conception, formulation, regulatory classification upfront, claim strategy, sample production, stability testing and scale-up to series production.

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

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## Product development from idea to series

Conception, formulation, regulatory classification upfront, claims, samples, stability and scale-up — development at INOPREX does not end on paper but in a released series.

Product development at INOPREX covers conception and formulation, formulation development and reformulation, regulatory classification upfront (medical device, cosmetic or supplement, including borderline assessment), claim strategy, selection of dosage form and primary packaging, sample production, stability and compatibility testing, supplier qualification, calculation and scale-up to series production.

## How development proceeds

1. **Briefing & feasibility** — We assess your product idea, intended claims, dosage form and regulatory framework — and tell you clearly what is feasible.
2. **Regulatory classification & claims** — Medical device, cosmetic or food supplement? We fix the classification before formulation and communication are developed.
3. **Formulation & samples** — Formulation development, stability testing and sample production — with qualified contract manufacturers and fillers in the EU.
4. **Technical documentation** — Technical documentation, PIF, labelling and claims are prepared completely and audit-ready — according to the applicable standards of each category.
5. **Production & release** — Series production in the qualified EU network, batch-related quality release and traceability from a single source.
6. **Market access & post-market** — Registration, EUDAMED/CPNP, vigilance and post-market surveillance accompany your product beyond market entry.

## What development delivers

- Formulation with specification, raw material list and sources
- Regulatory classification with justification (medical device class I/IIa/IIb, cosmetic or supplement)
- Claim strategy per category: MDR, Regulation (EC) No 1223/2009 or the Health Claims Regulation
- Stability and compatibility evidence (scope project-dependent)
- Calculation with MOQ and unit price ranges
- Handover to series production with release criteria