Services
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.
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Product development
Conception, formulation, regulatory classification upfront, claim strategy, sample production and scale-up to series.
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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.
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Private label
Exclusive new development to your briefing. Formulation and IP stay with the client, MOQ project-dependent.
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White label
Established, documented formulations — MOQ from 10,000 units per SKU, short time-to-market. Catalogue under NDA.
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Regulatory consulting
Audit preparation ISO 13485 and ISO 22716, gap analyses, claim review, training, interim PRRC.
Which service fits your project?
In an initial consultation we clarify which modules your project needs — development, legal manufacturing, consulting or a combination.