Project Management
“Our concept of project management involves the integration of individuals with varied skill-sets into multifunctional problem solving teams. This approach allows LexaMed to capitalize on the broad-based industrial experience of our staff and to provide the most appropriate and cost-effective practical solutions to a particular problem.”
- Bob Reich, LexaMed President
Expertise
Our Team of Consultants has expertise in all aspects of medical device and pharmaceutical operations, including, but not limited to:
- Process and Equipment Validation
- Sterilization – EO, Steam, VHP, Radiation, UV, Ozone, Pulsed-Light, Dry Heat
- Aseptic Processing
- Microbiology
- Chemistry - Method Development / Validation / Verification
- Environmental Monitoring
- Regulatory Compliance
- Quality Systems
- cGMPs – Device, Pharmaceutical, Biologics, Medical Gases
- Compliance Audits
- GAP Analysis to Regulatory Standards –
►Sterilization Compressed
►Medical Gases
►Aseptic Operations
Need a Quick Quote?
Please email your specific request, including name, company name, and desired timeframe to info@lexamed.net.
LexaMed Consulting Services
LexaMed offers consulting services in all aspects of the pharmaceutical, medical device and biotechnology industries. Our experienced consultants have over two centuries of accumulated experience and are recognized as subject-matter-experts in a variety of fields and are sought after speakers and educators at regulatory and industry conferences. They are active participants in many guideline and standard setting organizations such as AAMI, PDA, ISPE and ISO. Our consultants are, therefore, not only contemporary in their knowledge but are also influential in establishing industry practice and regulatory expectations.
Meet LexaMed's Core Team of Consultants
| Name and Title | Email Address | Download Curriculum Vitae |
| Robert R. Reich, President | rreich@lexamed.net |
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| James P. Kulla, Senior Vice President | jkulla@lexamed.net |
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| Robert M. Brown, Sr. Consultant, Quality Systems/Operations | rbrown@lexamed.net |
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| Ramon A. Burns, Jr. Ph.D., Sr. Consultant, Chemistry | rburns@lexamed.net |
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| Robert O. Dean, Sr. Regulatory Consultant | rdean@lexamed.net |
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| John Huffman, Sr. Consultant, Chemistry/Quality Systems | jhuffman@lexamed.net |
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| Carolyn Kinsley, Vice President, Microbiological Compliance | ckinsley@lexamed.net |
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| Donna Kohut, Sr. Consultant, Quality Systems/Regulatory | dkohut@lexamed.net |
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| James Latham, Sr. Consultant, Microbiology/Quality Systems | jlatham@lexamed.net |
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| Chris C. Lau, Sr. Consultant, Microbiology/Quality Systems | clau@lexamed.net |
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| Steve Rhoades, Project Manager | srhoades@lexamed.net |
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| Julia Roesner, Director of Information Technologies | jroesner@lexamed.net |
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| Philip Schneider, Sr. Consultant, Microbiology/Quality Systems | pschneider@lexamed.net |
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| Anne Schuler, Director of Quality Operations | aschuler@lexamed.net |
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| James G. Whitcomb, Technical Director, Toledo Operations | jwhitcomb@lexamed.net |
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| Xiao-qun Zeng, Sr. Microbiologist | xzeng@lexamed.net |
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LexaMed can also provide microbiology technicians, validation technicians, and quality system analysts; we have established strategic relationships with consulting organizations that enables us to address projects of any size or scope. Contact us today with your specifications.
