Beaufort, LLC, provides FDA regulatory consulting services to the medical device, in vitro diagnostics (IVD), pharmaceutical, and biologics industries worldwide. Our team of subject matter experts averages more than 20 years of experience helping clients successfully manage regulatory affairs.
FDA Regulatory Consulting services include:
- Comprehensive regulatory project plans and regulatory strategies
- Regulatory strategies, pre-IDE, 510(k) (traditional, special and de novo), IDE, IND, BLA, PMA, and PMA supplement submissions
- Liaise with FDA and authorized representatives
Beaufort, LLC, is an experienced consulting firm that has carried out hundreds of GMP and ISO quality system audits for medical device and pharmaceutical manufacturers in North America, Europe, and Asia. We have implemented quality management systems for companies with a diverse range of manufacturing processes.
Quality System Audit services include:
- Quality system audit readiness and execution
- Quality system training
- Internal/external quality system audits
Beaufort offers a comprehensive program of clinical research services and can manage your clinical trial from study design and start-up through final reporting, including data management, biostatistics, and monitoring support. Beaufort’s field monitors are highly experienced clinical research associates (CRAs) with a expertise in a wide variety of therapeutic areas.
Beaufort CRAs perform a full range of clinical trial monitoring responsibilities:
- Trial initiation and clinical monitoring on full range of visits in accordance with scope of work and GCP
- Interim and final reporting
- Evaluation of the quality and integrity of study site practices, and establishment of communication with sites to manage adherence to applicable regulations
Clinical Trial Management services include:
- Study and protocol design
- Clinical site/investigator evaluation, qualification, and selection
- Study management and coordination
To address the ever-increasing scrutiny of FDA, Beaufort’s quality oversight practice provides preemptive quality oversight of your clinical trial program to ensure product efficacy and safety.
Quality Oversight services include:
- Independent evaluation of the clinical trial monitoring process of vendors engaged by the sponsor
- Comprehensive, quantifiable analysis of high risk issues discovered at sponsor clinical trial sites
- Internal Quality Review of all reports to ensure the most accurate and complete assessment of the CRA and their adherence to the monitoring plan
Providing Customized Solutions to Our Clients
Beaufort’s experienced team works to resolve the many complex challenges of pharmaceutical, in vitro diagnostics, medical device, and biologics companies. We meet these challenges head-on and develop a solution to address the needs of each individual client.