Working in close partnership with our clients, we develop robust, compliant and commercially viable products ready for launch in the chosen market.
Our process begins with an evaluation of the business, product performance and clinical usability requirements of the product and technology evaluation. Throughout this stage of the process, we explore functional improvements that focus on optimising the product offering and maximising the return on the investment. Ownership of all newly created intellectual property developed by us is assigned to the client.
At the core of our process is the full development of a product, encompassing specifications, risk management, technology verification, product validation testing, manufacturing validation and clinical studies. We do everything in the technical file.
From the first prototypes to the full validated manufacture of your product, we work closely with our clients and drive the program through each stage of the innovation pathway. Through our trusted partners in the UK and our FDA accredited contract partners in Asia, we can support our clients with longer-term large-scale commercial manufacturing, or the transition of the production to their own facilities.
We deliver regulatory assessments and submissions, road-map planning, and complete the IVDD/IVDR CE marking and FDA 510(K) applications and ensure your product is compliant with all applicable global regulations to ensure each technology is ready for launch in the chosen market.
Through the delivery of a complete technical file, quality management system records and regulatory submission support documentation, we can ensure full traceability with a high level of efficiency.
Launching the product to market is the ultimate goal of our process and one which we have extensive experience in delivering for our clients. Our team supports our clients to create packaging and labelling, user manuals and launch support materials.
We work with our clients to both appoint and manage distributors in Europe and the USA. With a strong network of industry and healthcare contacts and partners, we help our clients achieve a commercial exit through sale or licensing.
