Product Realisation Services

Elucigene PRS enable customer to utilise our wealth of experience in the molecular diagnostics sector, offering bespoke services from assay development and validation, manufacturing, regulatory strategy, through to commercial sale and distribution.

Assay Design

With over a decades experience of diagnostics IVD assay design, Elucigene assist customer to achieving a simple and effective molecular diagnostic approach, utilising DNA amplification techniques including ARMS-PCR, qPCR, RT-PCR, QF-PCR and NGS. Assay design services include, testing strategy rational, target identification, primer design and optimisation.

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Proof of Concept

Facilitating early stages designs through to full proof of concept, enabling you to establish the clinical and technical merit of the identified testing strategy.

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Feasibility Manufacture & Production Validation

Our feasibility manufacturing and product validation services, enable you to identify the ease of manufacturing your product prior to embarking on a full manufacturing program.

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Internal Regulatory Guidance

Enabling products to achieve international regulatory clearance is at the heart our ethos, from product design and validation, through to developing and execute a regulatory approval strategy for both EU and non-EU markets.

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Routine Manufacturing

Our ISO 9001 and 13485 certified manufacturing facilities have the flexibility to offer pilot and single batch production, through to small or large scale routine commercial manufacturing.

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Market Entry Consultancy

The Elucigene PRS commercial team are able to facilitate premarket entry scoping in order to inform both the commercialization and regulatory strategy in order to maximized market opportunities. Services include clinical pathway, market sector and competitor analysis, as well as pricing and reimbursement strategy investigation.

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Direct to Market Sales

Offering a truly global reach through a direct commercial team, and in collaboration with 30 international partners, Elucigene are able to manage every stage of a product sales from KOL development and on site demonstration, to tender and pricing negotiations.

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