LexaMed’s team of industry professionals has over two centuries combined of pharmaceutical and medical device experience. The skill-sets of our consultants are complementary and allow us to address situations of varied subjects with technically compliant, practical comprehensive solutions. Our consultants are experienced in Quality Systems, Validation – of product, processes, equipment, aseptic operations, sterilization – radiation, ethylene oxide, VHP, steam, liquid, Regulatory Compliance, Microbiology, Engineering and Analytical Methods.
LexaMed Laboratories have been in operation for more than 30 years, initially as BEC Laboratories, now as LexaMed, providing quality services in microbiology and chemistry. Lab services include sterility testing, bioburden determinations, cytotoxicty, D and z-value determinations, BIER unit exposures, package integrity and container closure challenges, and 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. LexaMed is also an active member of BioOhio, MichBio, BioFlorida, and Florida Medical Manufacturers Consortium (FMMC).