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.

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 requirements.
  • 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.

About LexaMed

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).

Certifications

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.

For more information on our capabilities, please download our company brochure.

Ready to submit your sample for testing?  Please download our Sample Submission Form and return to the LexaMed sales team.