How Eagle’s Approach Gives Its Customers a Huge Advantage
As an industry leader in analytical testing and consulting services for 503A compounding pharmacies, 503B outsourcing facilities, and pharmaceuticals, Eagle Analytical embraces a philosophy called the ‘Eagle Shield’ to help customers get product to market faster, safely and with full compliance.
bioMérieux had the opportunity to sit down with Ashley Trueheart, former Director of Product Design and Development at Eagle Analytical (Eagle) to discuss how they provide customers the fastest time-to-results using SCANRDI®, a safe and proven method for sterile product release.
Eagle is an FDA-registered analytical testing and consulting service for 503A compounding pharmacies, 503B outsourcing facilities, and pharmaceuticals. Eagle’s scientific experts excel at helping sterile and non-sterile facilities identify risks, challenges, opportunities, and implement cost-effective, science-based solutions to resolve the needs of pharmaceutical companies.
Before her transition to another leading biotechnology research company, Ms. Trueheart was with Eagle for 7 years, starting as a microbiologist and advancing to microbiology manager, and then on to Director. As Director, she led product design, assisting customers in navigating regulatory compliance requirements and acted as the subject matter expert on SCANRDI® – a rapid microbiology solution with patented universal cell labeling and solid phase cytometry with the ability to detect bacteria, yeasts, molds, and spores.
Recognized by the FDA as an alternative method for sterile product release, SCANRDI® revolutionized rapid microbial detection when it was first introduced. Today its speed and sensitivity differentiates SCANRDI® as a leading alternative method in the industry. Eagle adopted the technology to provide its customers an edge by reducing the actionable sterility results to 4 hours or less, down to 1 microorganism of sensitivity.
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