Eagle is a U.S. Food and Drug Administration (FDA) and Drug Enforcement Agency (DEA) registered A2LA ISO 17025 accredited laboratory founded in 2003 that provides analytical and microbiological testing, consultation services, and other technical services for pharmacies, highly regulated industries, and research organizations to support their compliance needs.
OUR COMMITMENT TO YOU
It is our commitment to provide your organization with the tools to operate and maintain compliance within a highly regulated environment. In support of this commitment, Eagle is now home to professionals spanning the science and pharmaceutical industry, including experts in chemistry, microbiology, engineering, CGMP, quality control, and quality assurance.
Our scientific experts excel at helping sterile and non-sterile facilities identify risks, challenges, opportunities, and implement cost-effective, science-based solutions to resolve your needs. With our guidance, you will feel confident with your compliance.
Our state-of-the-art 35,000 square foot facility and laboratory features innovative technologies and more lab space so we can increase our efficiency and have faster turnaround times for our clients. This behind-the-scenes video gives you a tour of our laboratory and a chance to see testing as it is occurring.
With our interdisciplinary team, in addition to routine laboratory testing, Eagle is uniquely positioned to provide services in research and development, consulting, calibration, certification, validation, facility design, and compliance auditing.
Microbiology testing provides healthcare, pharmaceutical, and other regulated industries with testing that accommodates product development, validation, compliance, and provides qualitative and quantitative assessments of products.
Regulatory requirements from State Boards of Pharmacy, the FDA, and the DEA can be confusing and difficult to understand. Therefore, in addition to science-based testing and data interpretation solutions, Eagle offers consulting services that will guide and support your regulatory needs.
Before its first use, equipment is qualified as capable of performing its intended function through an Installation Qualification/Operational Qualification/Performance Qualification (IQ/OQ/PQ).
Calibration and Certification
After an IQ/OQ/PQ is completed, equipment is routinely inspected, calibrated, and checked to ensure proper performance.
Stability studies are performed in accordance with ICH Q1A guidelines to evaluate the chemical, physical, and microbiological properties of a product at predetermined storage conditions to assure that it meets standards of identity, strength, quality, and purity throughout its intended shelf life.
Stability-Indicating Method Development and Method Validation
The FDA requires that analytical methods be reliable, meaningful, and specific. Stability-indicating method development includes optimization of analytical conditions and chromatographic parameters to ensure appropriate resolution of the analyte from excipients, impurities, and potential degradation peaks.
Method Validation is performed in accordance with ICH Q2(R1) and includes system suitability, specificity including forced degradation/stress studies, linearity, accuracy, range, precision and intermediate precision, robustness, solution stability, and limit of detection (LOD) / limit of quantitation (LOQ) determination and confirmation (if applicable).
Additional Service Offerings
Eagle has a variety of service offerings designed to meet your distinct needs. With quick turnaround times, exceptional customer service, and more. Eagle is dedicated to being the one-stop shop for the industry.
DEDICATED TO HELPING YOU
Eagle helps facilities mitigate risk by providing compliance and safety solutions backed by science. This holistic approach allows Eagle to offer solutions that support your regulatory, business, and patient needs.
503A Compounding Pharmacies
503B CGMP Outsourcing Facilities
Clinical/Research and Development Organizations
Pharmaceutical Manufacturers and Repackagers
Get Started Today
Call the Eagle Client Care Team at 800.745.8916 to request an initial consultation and discuss your operation’s specific needs.
Your Future Awaits
Our talents vary — but we all have the same drive: to find better ways to improve the lives around us. If you are looking to become part of a company that is growing and innovative, Eagle may just be what you are looking for.