About Eagle

Eagle Analytical is an FDA-registered analytical testing and consulting service for the pharmaceutical industry, with specialized services for 503A compounding pharmacies and 503B outsourcing facilities. We offer the highest quality in preparation testing for sterility, bacterial endotoxins, microbial detection, and active ingredient potency.

What We Do

Through the experience and scientific mastery of our team, we’re serving compounding pharmacies by testing routine samples, helping fine-tune formulations, providing feedback on techniques while offering compliance solutions to meet your operational and regulatory needs.

Microbiological & Analytical Testing

  • Rapid Scan RDI – Bacteria, Mold, and Fungal Test
  • Potency Testing
  • Analytical Method Development
  • API – Active Pharmaceutical Ingredient Identification
  • Endotoxins
  • Lot Release Testing
  • Stability Studies

Lot Release Testing

  • Potency testing
  • pH/Appearance
  • USP <61> Microbial Enumeration
  • USP <62> Objectionable Organisms
  • USP <51> Anti-Microbial Effectiveness
  • USP <85> Bacterial Endotoxins
  • USP <788> Particulate Count
  • USP <1207> Container-Closure Integrity

Stability Studies

  • Product Development/Stability Indicating Assays
  • Stability Testing Protocol & Program Development
  • Statistical Analyses of Data Collected
  • Stability studies compliant with GMP, ICH, and USP guidelines

Education

Pharmacies

  • Outsourcing Facilities
  • Manufacturing & Repackaging Facilities
  • Universities
  • Hospitals
  • Clinical Trial Sponsors & Investigators

INDs, NDAs, ANDAs, and Product Nominations

  • Development of Analytical Testing Protocols
  • Product Development/Stability Studies
  • Product Submissions & Nominations

 

FDA 483 and Warning Letter Responses

Pre-Registration Audits (Outsourcing Facilities)

How We Deliver The Results

Eagle is registered with the FDA, the DEA and the Texas Department of Public Safety, allowing us to offer a wide range of testing capability.

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