EAGLE IS MORE THAN TESTING, LET OUR KNOWLEDGE WORK FOR YOU

GAP ANALYSIS AUDIT | COMPLIANCE SOLUTIONS & CONSULTING | CALIBRATIONS & CERTIFICATIONS | TESTING | & MORE

About Eagle

ABOUT US

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 chemistry 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 EXPERTS

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 LABORATORY

Our state-of-the-art 30,000 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.

SERVICE OFFERINGS

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.

Chemist inputting data into computer terminal

Analytical Testing

Analytical testing is a valuable quality control tool that evaluates and supports the suitability, quality, and conformance of your drug product to predetermined specifications.

A microbiologist looking at a contact plate under a magnifying glass.

Microbiological Testing

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.

3 Eagle consultants at a table with a blueprint and other paperwork and a computer. One consultant looking at a tablet.

Consulting Services

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.

Engineer, Director of Operations Frank Allen, conducts testing in an Eagle cleanroom.

Equipment Qualification

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).

A Smoke Study being performed inside an ISO 5 hood under dynamic conditions.

Calibration and Certification

After an IQ/OQ/PQ is completed, equipment is routinely inspected, calibrated, and checked to ensure proper performance.

Image of glass doors leading to Eagle's Microbiology laboratory cleanroom

Stability Testing

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.

Contact us about your unique needs and requirements.