Quality Control / Analytical Testing
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Associates of Cape Cod, Inc.
The Leader in Endotoxin and Glucan Detection.
Our worldwide headquarters in East Falmouth, MA with ISO 13485:2003 certified, FDA Inspected and DEA Licensed laboratories and our Beacon Diagnostics® laboratory is CLIA-certified. We also have offices in the UK and Germany and distribution in over 80 countries. Products: Our reagents and instruments are used within the Pharmaceutical, Medical-Device and Biotechnology industries for quality control and product release. We offer FDA licensed reagents and USP/BET Compliant instrumentation. Services: ACC’s CTS laboratory specializes in testing for endotoxin and glucan contamination and has the most extensive experience of any endotoxin and glucan testing laboratory in the world. Our Beacon Diagnostics® laboratory is a CLIA-certified laboratory specializing in (1-->3)-ß-D-glucan analysis to support the diagnosis of Invasive Fungal Disease (IFD).
Analytical Research Laboratories
High-Quality Service through Experience and Excellence
Analytical Research Laboratories (ARL) is a contract research laboratory. ARL provides analytical and microbiological testing for compounding pharmacies and outsourcing facilities. ARL is an ISO 17025:2005 accredited laboratory, FDA registered and DEA licensed. Laboratory services routinely include: sterility, endotoxin, potency, stability and compatibility studies, full compendial testing, and method development and validation. Non-GMP and cGMP services are available depending on client requirements.
Eagle Analytical Services
When You Think Quality, Think Eagle
Eagle Analytical Services specializes in Quality Assurance/Quality Control testing for the compounding pharmacist. Quality assurance and control are becoming ever more important in today’s compounding pharmacy environment. Heightened public awareness, increased regulatory attention, and most importantly, the desire of pharmacists to provide the highest quality preparations for their patients while improving their pharmacy operations, all have created increased interest in quality assurance and control. Dedicated to the unique needs of compounding pharmacies, Eagle provides sterility (bacterial and fungal), endotoxin, and active ingredient potency testing. For rapid sterility testing, Eagle Analytical is unique in providing the bioMérieux Scan RDI™ Rapid Microbial Detection Protocol. Accurate compositional analysis is performed using HPLC systems with USP or other certified reference standards. Online laboratory reports are available, and lab results are archived for easy retrieval. Rush services are available. Log onto www.eagleanalytical.com for details regarding sample sizes required for analysis and a sample submission form. Call Eagle Analytical at 800-745-8916.