Eagle provides expert scientific solutions, including analytical chemistry, microbiology testing, and R&D services. We specialize in validations, regulatory consulting, facility design, and cleanroom certifications — ensuring precision, compliance, and efficiency for your success.
Company Background
Founded in 2003, Eagle began as a trusted partner in regulatory support for the compounding industry. Today, we are a premier scientific solutions provider with an FDA-registered CGMP testing and calibration lab spanning 80,000+ square feet. With 200+ years of combined expertise in the FDA-regulated pharmaceutical industry, 300+ services, and state-of-the-art technology, we help facilities mitigate risk with science-backed compliance and safety solutions.
Product Overview
Laboratory Testing
Our segregated laboratory equipped with advanced technologies provides analytical chemistry and microbiological testing services. From raw materials to finished drug products, we support a wide range of pharmaceutical and compounding testing needs.
Our patented method for testing oil-based compounded products using ScanRDI® sets us apart — delivering fully compliant, rapid sterility results with a one-day turnaround. Additional services include microbial enumeration, endotoxin testing, method verification and validation, preservative efficacy, and stability testing, all designed to meet CGMP and USP requirements.
Validation Services
Eagle offers a comprehensive suite of validation services to support your regulatory compliance and product quality goals. Our expertise ensures that your processes, methods, and cleaning procedures meet industry standards and regulatory expectations. We provide cleaning validation, disinfectant efficacy studies, stability indicating method development and validation, USP monograph method verification, and microbiology method validations and suitability testing.
Consulting
Our consulting team delivers customized GAP audits, due diligence audits, regulatory response support, SOP development, and environmental monitoring solutions. We also manage projects involving cleaning validations, disinfectant efficacy testing, stability studies, sterilization and depyrogenation cycle validations, aseptic process validations, facility design, and other specialized projects upon request.
Certification and Calibration
Our engineers understand the vital role environmental control systems play in ensuring product quality and employee safety. We perform cleanroom certifications (including primary and secondary engineering controls, and fume hoods), equipment calibration, and equipment qualification (IQ/OQ/PQ). Following IQ/OQ, our team completes performance qualification (PQ) to confirm the equipment operates as intended, ensuring consistency and reliability.
Testimonial
“Our experience with Eagle has gone beyond getting reliable and accurate data on our daily testing needs. Eagle’s highly trained team provides quick solutions to our problems through their quality consultative services and courteous care. Being a customer of Eagle is a privilege. It’s a confident decision to add value to our businesses.” — Sherry Eghtesadi, Rancho Park
Markets Served
Eagle is uniquely positioned to serve a diverse range of clients, including pharmaceutical drug and device manufacturers, 503B outsourcing facilities, 503A compounding pharmacies, hospitals, and clinical research organizations. Our services reach clients across North America and globally.
