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.
Company’s Keywords:
extractables, leachables, medical device analysis, method development, method validation, bioavailability, impurity identification, characterization, stability programs, deformulation, regulatory consulting, usp 661 testing, chemical analysis, pharmaceutical analysis, pharmaceutical testing, chemical testing, medical device testing, failure analysis, combination product testing, combination product analysis
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