Elucigene Product Realisation Services
Do you have a product idea, but you are unsure how to commercialise it?
The Elucigene Product Realisation Service gives you the opportunity to utilise our wealth of experience in the molecular diagnostics sector. We offer a bespoke service dependant on your needs, guiding you through the product development and commercialisation process.
Step 1: Assay Design
We have been designing in vitro diagnostic kits for over a decade. Elucigene can advise on product design, offering expertise in target identification, primer design, primer optimisation and testing rational.
Step 2: Proof of Concept
We will advise on proof of concept investigations, enabling you to establish the clinical and technical merit of your product.
Step 3: Feasibility Manufacture and Product Validation
We will help plan your manufacturing programme, aiding the development of effective and well documented validation and verification requirements which are essential for assay development within medical device regulations. This will ensure your device and subsequent processes will have full compliance, better reproducibility, reduced production costs and faster time to market.
Step 4: Market Entry Consultancy
The Elucigene commercial team will facilitate pre-market entry scoping, in order to inform both the commercialisation and regulatory strategy to maximise market opportunities. Services include Key Opinion Leader development, clinical pathway analysis, pricing and reimbursement investigations and competitor analysis.
Step 5: Regulatory Planning
Enabling products to achieve international regulatory clearance is at the heart of our ethos. We will help you design and execute a regulatory plan for both EU and non-EU markets.
Step 6: Routine Manufacture
Our ISO 13485 certified manufacturing facilities have the flexibility to offer a range of services, from single batch production to routine large-scale commercial manufacturing.
Step 7: Direct to Market Sales
Offering a truly global reach through our direct commercial team, in collaboration with 30 international partners, Elucigene are able to manage every stage of the product sales process, from customer demonstrations to tender and pricing negotiations.