SERVICES

Project Process

A Project Journey with Dx assays

Upon receiving a service query, we will engage our marketing and technical staff to define client requirements, scope and deliverables of the project, as well as the budget and time estimate. A service proposal will be generated and presented to the client. If required, a regulatory strategy will be formulated through partnership with regulatory firms. A feasibility study may be conducted at this stage for the client to have better understanding and evaluation before full commitment to the program.

Upon signing of the service contract, our experienced and dedicated scientists will carry out assay development and validation activities in full compliance to ISO 13485 certified quality system. Our core “Design and Development” process defines the movement of product from concept to market. A Design History File will be established during the course of assay development and validation, and will be handed over to the client upon completion. In addition, client communication (channels, frequency and content) will be defined so as to ensure sufficient information exchange and transparency in project’s progress.