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.
- Case Study: The Value of Independent Quality Oversight for Sponsors
- Challenge: A world leader in tissue-based cancer diagnostics based in Denmark was notified by the FDA that it was not in compliance with the ASR regulation. The company submitted a project plan to become compliant, but after the FDA did not respond for more than a year, the company sought assistance resolving the issue and dealing with the FDA.
- Challenge: 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.
- Challenge: The U.S. subsidiary of a large, international pharmaceutical company identified a broad range of actions to increase its readiness for an upcoming FDA inspection.
- Challenge: A small, direct-to-patient provider of wound supplies and compression therapy products needed assistance with an audit of its manufacturing supplier, as well as audits associated with an ongoing clinical trial.
- Challenge: A large U.S. manufacturer of medical devices, instrument systems and reagents needed audits conducted at several clinical trial sites.
- Challenge: A leader in molecular diagnostic innovation needed to review its document control system.
- Challenge: A leading innovator in diagnostic and therapeutic products needed additional resources to manage three clinical trials in support of 510(k) submissions to FDA.
- Challenge: A company that offers comprehensive contract manufacturing services required regulatory support.
- Challenge: A molecular diagnostics company developing proprietary nanotechnology to enable earlier detection and treatment of disease needed assistance conducting clinical trials in support of a 510(k) submission to FDA.