COMPANY DESCRIPTION
Eagle is an FDA- and DEA-registered, A2LA ISO 17025-accredited, CGMP laboratory that provides analytical chemistry, microbiological testing, consulting, and technical services. Eagle serves pharmacies, pharmaceutical manufacturers, GMP-compliant organizations, research institutions, and other highly regulated industries throughout the United States and internationally, supporting their compliance and quality assurance needs, from raw materials to finished products. Eagle offers more than 300 services and delivers science-based compliance and safety solutions to help facilities mitigate risk and ensure patient safety.
COMPANY BACKGROUND
Founded in 2003 to address the regulatory needs of the compounding industry, Eagle has since evolved into a distinguished FDA-registered CGMP testing laboratory and consulting organization. Operating out of an 80,000+ square foot, state-of-the-art facility, our expanded expertise now encompasses an extensive range of testing and consulting services to support regulatory compliance and industry excellence.
MARKETS SERVED
Eagle is uniquely positioned to serve a diverse range of clients, including 503A compounding pharmacies, 503B outsourcing facilities, CCGMP-compliant organizations, hospitals, pharmaceutical drug and device manufacturers, and clinical research organizations.
PRODUCTS, SERVICES & CAPABILITIES
Eagle provides an extensive range of analytical chemistry and microbiological testing services for raw materials, f i nished pharmaceutical products, and medical devices, ensuring compliance with regulatory standards. This includes rapid sterility testing, stability studies, and method validation, all aligned with CGMP and USP standards. Eagle also offers validation services to ensure processes, methods, and cleaning procedures meet regulatory expectations, along with consulting support for audits, SOP development, environmental monitoring, and specialized projects such as aseptic process validation and facility design. In addition to designing cleanrooms, Eagle performs cleanroom certifications, equipment calibration, and qualification services to ensure critical environments and systems operate reliably and safely. We also offer TSA media plates and the SurfaceShield Wipe Sampling Kit to enhance any environmental monitoring program. Eagle is committed to being your all-in-one solution provider.