Regulatory Strategy and Compliance Case Studies
Beaufort has provided regulatory strategy and compliance, clinical research, and quality assurance services to both established and emerging diagnostic companies. The following case studies describe specific solutions that we have tailor-made for our diagnostics company clients.
A leader in molecular-based diagnostic tests and testing platforms sought assistance in developing its regulatory strategy for repositioning several analyte-specific reagents (ASRs). The company wanted a comprehensive regulatory perspective encompassing the various potential pathways for converting ASRs into diagnostic kits, as well as assistance in creating the pre-IDE information packages for each product. Working with the company’s internal resources, Beaufort completed this assignment, and, in addition, reviewed relevant literature and created a pre-IDE information package which included a high level clinical trial protocol for FDA review.
A subsidiary of a global molecular diagnostics company needed assistance developing an effective regulatory strategy for a drug-of-abuse assay. In-house clinical trial plans and previous 510(k) submissions had been rejected by the FDA. The company engaged Beaufort to redefine the intended use of the assay and provide guidance regarding effective interactions with FDA. Beaufort redefined the intended use to specify the results of the product and to enable FDA to focus on the potential positive uses of the product. After previous applications, literature, and data were reviewed, Beaufort redesigned a clinical trial protocol that would support the new intended use of the assay, providing appropriate focus on the actual functionality of the product. This done, the client was positioned to move forward in their plans for the product.
A division of a global molecular diagnostics company needed a regulatory strategy for a completely new technology. Division management had a clear plan for the scope of their product but lacked the regulatory expertise necessary to devise the most time and cost-effective approach for launching a new product. The company engaged Beaufort to develop a comprehensive regulatory strategy focusing on all aspects of the new technology, including targets and methodology. Beaufort provided a complete regulatory strategy that assessed the possible pathways for the product, as well as timelines, associated tasks, and costs for each type of submission. The client is using this strategy to plan its product development.
A leader in assay and sample technology development for tests used in the pharmaceutical and molecular diagnostics industries needed a regulatory strategy for its analyte-specific reagent (ASR) diagnostic kits. After identifying pathways to a Class II device classification, Beaufort prepared a strategic regulatory plan for the test kit, enabling the company to satisfy regulatory requirements in a cost-effective manner. Beaufort drafted a pre-IDE filing, including a clinical trial plan, and provided coaching to the client as they prepared for their pre-IDE meeting with the FDA. After successful meetings with FDA officials, the company relies on Beaufort for continued support as necessary, including assisting with pre-clinical and clinical trial activities.
