Product development from idea to 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. 01

   Briefing & feasibility

   We assess your product idea, intended claims, dosage form and regulatory framework — and tell you clearly what is feasible.

2. 02

   Regulatory classification & claims

   Medical device, cosmetic or food supplement? We fix the classification before formulation and communication are developed.

3. 03

   Formulation & samples

   Formulation development, stability testing and sample production — with qualified contract manufacturers and fillers in the EU.

4. 04

   Technical documentation

   Technical documentation, PIF, labelling and claims are prepared completely and audit-ready — according to the applicable standards of each category.

5. 05

   Production & release

   Series production in the qualified EU network, batch-related quality release and traceability from a single source.

6. 06

   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