FDA News and More
LexaMed is pleased to announce the addition of Jerome Bell to our executive management staff. Read More...
LexaMed Senior Vice President Carolyn Kinsley recently provided training to FDA personnel on Ethylene Oxide sterilization. Read More...
LexaMed elects a new member to the Board, Mr. Tom Bienias. Read More...
LexaMed now maintains a FDA Drug Registration in addition to the existing Device Registration. Read More...
LexaMed is pleased to announce the expansion of its FDA-registered, ISO 13485 certified laboratory operation to include the testing of fabrics used to manufacture gowns and drapes... Read more...
LexaMed offers consulting services in many aspects of the pharmaceutical, medical device and biotechnology industries, provides a full complement of microbiology and chemistry services from our corporate laboratories, and manufactures BEC Growth-ChekTM Microbial Suspensions that are derived from cultures traceable to a recognized culture collection identified in USP. Moreover, LexaMed compliments its compliant consulting and validation services, laboratory operations and microbial suspension product line with additional integrated services in quality management systems, regulatory compliance consulting, auditing, dietary supplements compliance assessments, sterilization packaging systems, cleaning and sterilization validation of reusable devices, client research & development, environmental monitoring, and training and seminars. Please contact us to discuss your specific requirements and determine how our staff can best support you and your valuable operation.
Compliance, Education, Analysis, Client & Knowledge Driven
Quality Biologics, Pharmaceutical & Medical Device Consulting, Validation Services, Certified Laboratory Testing Services, Client R&D, Training & Seminars, and BEC Growth-ChekTM Product Line
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 certified 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 have been in operation for more than 25 years, initially as BEC Laboratories, now as LexaMed, providing quality services in microbiology and chemistry. Lab Services have been expanded to include many other offerings including 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. LexaMed is also an active member of BioOhio, MichBio and PennBio.
LexaMed 's mission is to offer quality, compliant value-added services and products to our clients in a courteous and expeditious manner at a fair price.
LexaMed Values Quality
LexaMed Quality Policy
LexaMed is committed to providing the medical device and pharmaceutical industries with the highest quality services and setting the standard for exceptional customer service. The quality of the service we deliver and the products we provide must always be of the highest quality. We as a company and as individuals are committed to continually exploring ways to improve our business and to exceed our clients’ expectations. We will accomplish these goals by:
►Continually monitoring turn around times to ensure on time delivery of our products and services.
►Providing accurate, error free work.
►Conducting testing using state of the art methods and equipment that meets or exceed regulatory
►Offering consulting services that provide competent assistance and timely solutions.
►Maintaining a professionally trained staff and providing on-going training programs to ensure
that our scientists are experts in their fields.
Quality is the responsibility of all employees and in order for LexaMed to succeed it will be the priority of all to meet the quality expectations of this policy.
LexaMed Quality Services
LexaMed offers quality services in all aspects of the pharmaceutical and medical device industries including niche markets. More specifically, LexaMed has experience in dealing with pharmaceutical companies that produce a variety of drugs in varied formulations which may include tablets, capsules, injectables, suppositories, sprays, powders, oral liquids, and semi-solids. For device manufacturers, LexaMed has experience in dealing with companies that produce a variety of devices from the design phase through the development stages. We have executed projects scoped at implementation of only one system to all quality systems for facilities located both domestically and internationally.