LexaMed is a company dedicated to providing the pharmaceutical, medical device and biotechnology industries with quality, compliant, state-of-the-art services in the areas of consulting, auditing, and laboratory testing. LexaMed’s team of industry professionals has over two centuries of pharmaceutical and medical device experience. The skill-sets of our consultants are complementary and allow us to address situations of any subject or scope with technically compliant, practical comprehensive solutions. Our consultants are experienced in Quality Systems, Validation – product, process and equipment, Aseptic operations, Sterilization – radiation, ethylene oxide, VHP, steam, liquid, Regulatory Compliance, Microbiology, Engineering and Analytical Methods.
LexaMed laboratories are ISO certified and provide quality services in microbiology and chemistry. Lab services include many offerings such as D and z-value determinations, BIER unit exposures, package integrity and container closure challenges, stability and accelerated aging under ICH specified conditions. Dedicated laboratory space and personnel are available for the execution of custom R&D protocols. LexaMed is ISO 13485 Certified, holds a State of Ohio drug license and DEA registration, retains a FDA registration for both medical devices and pharmaceuticals, and maintains active memberships in AAMI, ACS, ASM, ISPE, PDA, and RAPS.
Company’s Keywords:
microbiology, pharmaceutical, medical device consulting, quality assurance, certified laboratory testing services, client r, d, training, seminars, regulatory compliance, environmental monitoring, sterilization technology, auditing
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