Eagle
Eagle Analytical Services is a U.S.-based, FDA and DEA registered, A2LA ISO 17025 accredited laboratory founded in 2003. It provides comprehensive analytical chemistry and microbiological testing, consulting, calibration, certification, and validation services to support compliance in highly regulated industries including pharmaceuticals, pharmacies, research organizations, and medical device companies. Eagle is committed to patient safety, regulatory compliance, and innovative scientific solutions, with a focus on rapid testing methods, quality assurance, and industry-leading expertise. The company employs advanced technologies such as rapid microbial detection (ScanRDI®), metagenomic sequencing, and automation to enhance testing efficiency, sensitivity, and accuracy. It offers a variety of services including microbial testing, sterility testing, environmental monitoring, stability studies, and facility qualification, tailored to meet evolving regulatory standards like USP <797>, <800>, and cGMP. Eagle actively participates in industry events, collaborates with regulatory agencies, and continuously adopts new methodologies to ensure the safety and quality of pharmaceutical and water-based products. Its recent research highlights the detection of specific microorganisms in groundwater, including pathogenic bacteria and resistance genes, emphasizing its role in microbiological evaluation and public health protection.
Industries
Nr. of Employees
small (1-50)
Eagle
Houston, Texas, United States, North America
Products
Wipe sampling and cleaning verification kit
Pre-packaged wipe sampling kit and analytical workflow for detecting and quantifying hazardous drug residues on surfaces to verify cleaning and decontamination efficacy.
Real-time sample management platform
Web and mobile platform for clients to search submissions, receive real-time sample updates, view live results and process control charts, download reports, and pay invoices online.
Wipe sampling and cleaning verification kit
Pre-packaged wipe sampling kit and analytical workflow for detecting and quantifying hazardous drug residues on surfaces to verify cleaning and decontamination efficacy.
Real-time sample management platform
Web and mobile platform for clients to search submissions, receive real-time sample updates, view live results and process control charts, download reports, and pay invoices online.
Services
Laboratory microbiology and analytical chemistry testing for finished products, raw materials, and environmental samples to support release testing and regulatory compliance.
Sterility testing using compendial culture methods and validated rapid-detection platforms to expedite release while performing method suitability for each formulation and container-closure combination.
Regulatory interpretation, gap analyses, remediation planning, SOP development, training, and audit support for USP and FDA expectations and cGMP readiness.
Calibration of laboratory and facility instruments, equipment qualification, temperature mapping, and facility design reviews to support commissioning and regulatory compliance.
Validation programs including process validation, cleaning validation, sterilization and depyrogenation cycle validation, container-closure integrity testing, and supporting documentation for product release.
Design and implementation of environmental monitoring programs including sampling strategies, trending, corrective actions, and support for regulatory inspections.
Laboratory microbiology and analytical chemistry testing for finished products, raw materials, and environmental samples to support release testing and regulatory compliance.
Sterility testing using compendial culture methods and validated rapid-detection platforms to expedite release while performing method suitability for each formulation and container-closure combination.
Regulatory interpretation, gap analyses, remediation planning, SOP development, training, and audit support for USP and FDA expectations and cGMP readiness.
Calibration of laboratory and facility instruments, equipment qualification, temperature mapping, and facility design reviews to support commissioning and regulatory compliance.
Validation programs including process validation, cleaning validation, sterilization and depyrogenation cycle validation, container-closure integrity testing, and supporting documentation for product release.
Design and implementation of environmental monitoring programs including sampling strategies, trending, corrective actions, and support for regulatory inspections.
Expertise Areas
- Microbiological testing and sterility assurance
- Environmental monitoring and cleanroom qualification
- Metagenomic sequencing and water microbiome analysis
- Resistome profiling and antimicrobial-resistance surveillance
Key Technologies
- Shotgun metagenomic short-read paired-end sequencing
- Metagenomic annotation and resistome profiling pipelines
- Short-read library preparation and low-input linear-amplification workflows
- Fluorescence laser-scanning cytometry for microbial detection
News & Updates
Attend the AzPA Convention to learn about trends shaping the future of pharmacy and meet Eagle experts.
Join Eagle at the ASHP Summer event to explore pharmacy practice innovations and network with industry leaders.
Eagle presents at the 2025 CPC Congress in Boston, focusing on interpreting USP <795> and <797> requirements.
Eagle participates in the 2024 PCCA Seminar, emphasizing new trends in compounding and regulatory updates.
Eagle attends the HCP Fall event to discuss compliance and safety in hospital pharmacy settings.
An overview of the rapid sterility testing method ScanRDI® and its regulatory acceptance as an alternative to traditional USP <71> methods.
Attend the AzPA Convention to learn about trends shaping the future of pharmacy and meet Eagle experts.
Join Eagle at the ASHP Summer event to explore pharmacy practice innovations and network with industry leaders.
Eagle presents at the 2025 CPC Congress in Boston, focusing on interpreting USP <795> and <797> requirements.
Eagle participates in the 2024 PCCA Seminar, emphasizing new trends in compounding and regulatory updates.
Eagle attends the HCP Fall event to discuss compliance and safety in hospital pharmacy settings.
An overview of the rapid sterility testing method ScanRDI® and its regulatory acceptance as an alternative to traditional USP <71> methods.