EKG Life Science Solutions, LLC Logo - medical devices

EKG Life Science Solutions, LLC

medical devices
China's Best One-Stop Medical Equipment Provider
About

EKG Labs (EKG Life Science Solutions, LLC) is an analytical laboratory that supports medical device and pharmaceutical companies seeking to fast-track their product development. We excel at providing analytical and regulatory services which enable clients to fulfill complex regulatory testing requirements and bring their product to market faster. EKG Labs'​ specialty is providing services for products that have both a medical device and drug component. Often the components of a drug-device combination product interact in unique and fascinating ways. Our analytical expertise helps clients deduce if these interactions impact the safety or efficacy of their product. Our analytical expertise includes: extractables & leachables programs, biocompatibility, material compatibility, chemical characterization, impurity identification, method development, method validation, cGMP analytical services, GLP analytical services, failure investigations, and deformulation services. EKG Labs is a certified woman-owned business, and our facilities are FDA audited and DEA approved for schedule I-V substances.

Technologies
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Keywords
extractablesleachablesmedical device analysismethod developmentmethod validationbioavailabilityimpurity identificationcharacterizationstability programsdeformulationregulatory consultingusp 661 testingchemical analysispharmaceutical analysispharmaceutical testingchemical testingmedical device testingfailure analysiscombination product testingcombination product analysismedical equipment manufacturingmicrobial identificationdrug-device compatibility testingb2biso 17025validation servicesregulatory supportbioburden testingenvironmental monitoringbiological indicator qualification
Company Information
  • Employees6
  • Founded2013
  • Annual Revenue$15098000
Location

2250 Welsch Industrial Ct, St. Louis, Missouri, United States, 63146

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