Beaufort, LLC, offers a broad range of biologics consulting services in multiple therapeutic areas for regulatory strategy and compliance, clinical research, and quality assurance and compliance.
Beaufort helps develop and implement customized regulatory strategies designed to optimize the development of new biologics, and to reposition or expand the market for existing biologics. Our biologics regulatory services cover everything from strategy and protocol design to BLA submissions and annual reports.
Beaufort has a strong background in managing Phase I – 4 trials in multiple therapeutic areas. Our clinical research associates (CRAs) are experts with a minimum of eight years of experience. Their expertise and low turnover rate results in the highest quality clinical trial monitoring for our biologics clients.
Data integrity and patient safety are critical to sound clinical studies. With the number of FDA warning letters to sponsors on the rise, it has become increasingly important for companies to employ efficient and accurate strategies for monitoring. As a directed response to FDA quality system regulations, Beaufort is the first contract research organization to offer quality oversight services. Our high-caliber quality oversight team provides uniform, consistent and quality-focused evaluations.
Beaufort helps develop, implement and maintain the quality systems essential for biologics companies to remain compliant. From quality system audits to production and process controls to supplier management, Beaufort’s services cover all aspects of quality assurance and compliance for both new and existing biologics products.
- Gene therapy
- Preventative Vaccines
- Cancer Vaccines
- Blood and blood components