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....... A New Name - Same
Experience, Competence and Service
What's in a name????
Lex = Latin for a set of governing rules or standards
Med = Represents a company offering consulting and laboratory support
based on the rules and standards that govern the medical and
pharmaceutical industries.
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, laboratory and contract sterilization. Our 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, practice 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.
Our laboratories have been in operation for more than 25 years as BEC Laboratories providing quality services in microbiology and chemistry. These labs 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 custom R&D protocols.
LexaMed offers contract ethylene oxide sterilization in an ISO 11135 certified operation. Our four-pallet sterilizer is also ideal for cycle development and contract R&D studies.
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:
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Continually monitoring turn around times to ensure on time delivery of our products and services. |
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Providing accurate, error free work. |
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Conducting testing using state of the art methods and equipment that meets
or exceed regulatory requirements. |
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Offering consulting services that provide competent assistance and timely
solutions. |
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Maintaining a professionally trained staff and providing on-going training programs to ensure that our scientists are experts in |
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.
Mission Statement:
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.
ISO EN 550 and Q9001 Certified
LexaMed holds a State of Ohio Drug license.
Member of:
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AAMI |
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ASM |
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PDA |
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RAPS |
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ISPE |
Quality Validation, Sterilization, Research and Development, and Consulting
©2006
LexaMed, Ltd. All Rights Reserved.