The development of a biomarker assay into a companion diagnostic test is a complex process requiring input from multiple teams including project management, laboratory, bioinformatics and biostatistics, research and development, quality control, operations, manufacturing, quality, regulatory affairs, clinical affairs and marketing.
Diagnostic product development is a multifaceted process which is underpinned by a formal design control process. The activities involved in the product development process are driven by multiple factors including technology platform and the required regulatory strategy. Key activities include design control, production of development and pilot Investigational Use Only (IUO) lots, hardware development, software development, packaging, labelling and preparation for clinical trial validation studies.
The FDA requires that medical device manufacturers wanting to market certain types of products in the US follow specific design control requirements. These are a formalised set of steps focused on managing the design of the product.
With a wealth of experience in managing products through the design control process, we can provide support at each step of this process.
Investigational Use Only (IUO) products
An IUO product is an IVD product that is required for product testing prior to full commercial launch. From our ISO13485 cGMP manufacturing facilities in the UK, Tepnel Pharma Services can support your companion diagnostic development study by the production of investigational use only assays for use in analytical and clinical validation studies.