Eagle, established in 2003, began as a dedicated partner addressing regulatory needs in the compounding industry. Over the years, it has evolved into a premier scientific solutions provider, with a distinguished FDA-registered CGMP testing/calibration laboratory spanning over 80,000 square feet. Equipped with state-of-the-art instrumentation, cutting-edge technologies, and advanced methodologies, Eagle delivers tailored, high-quality scientific solutions designed to meet the most rigorous industry standards.
Eagle is uniquely positioned to serve a diverse range of clients, including:
- Pharmaceutical drug and device manufacturers
- 503B outsourcing facilities
- 503A compounding pharmacies
- Hospitals pharmacies
- Clinical research organizations
We proudly serve clients throughout North America and globally.
Eagle offers a comprehensive range of scientific solutions. Our laboratory provides analytical chemistry and microbiological testing services for raw materials, medical devices, and finished and compounded pharmaceutical products.
Eagle is the only lab in the USA offering three alternative rapid sterility tests in addition to traditional USP 71 sterility testing, making us an industry leader in rapid sterility testing. With its patent for testing oil-based compounded products on ScanRDI®, Eagle provides a fully compliant 1-day turnaround rapid sterility test. We help our customers reduce quarantine time by up to 90% with these advanced alternative methods.
Our team of experts also handle projects for:
- Cleaning validations
- Disinfectant efficacy testing
- Stability studies
- Sterilization cycle validation
- Depyrogenation cycle validation
- Aseptic process validation
- and any other special project upon request
Our consulting team provides customized GAP audits, due diligence audits, regulatory responses, SOP development, environmental monitoring solutions, designated person competency assessment and any other needs upon request. In addition, our engineering specialists excel in facility design, cleanroom certifications, smoke studies, equipment calibration and equipment qualification (IQ/OQ/PQ).
As part of our comprehensive Environmental Monitoring (EM) solutions, we provide TSA (Tryptic Soy Agar) plates in two convenient sizes, designed for both personnel monitoring and surface sampling. In addition to our high-quality plates, we offer a range of complementary services to support your monitoring needs:
- Incubation and Enumeration of Media
- Microbial Identification
- Temperature Mapping
- Incubation Qualification
To verify the efficacy of cleaning programs, we offer SurfaceShield, a wipe sampling kit designed to detect both hazardous and non-hazardous drugs on surfaces. This versatile and cost-effective kit supports achieving and maintaining USP <800> compliance and meeting Title 21 Part 211 CFR requirements. Additionally, we test for the majority of drugs listed in the NIOSH guidelines.
These integrated services ensure precise and reliable results, helping you maintain the highest standards of quality and compliance.
With our broad expertise, Eagle is your all-in-one solution provider.
