 |
|
|
|
| |
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 our knowledge but are also influential in establishing industry practice and regulatory expectations.
“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
Our Team of Consultants has expertise in all aspects of medical device and pharmaceutical operations, including:
|
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
|
Meet Our Core Team of Consultants |
|
| Name | Email Address Curriculum Vitae |
| Robert R.Reich, President | rreich@lexamed.net rreich.pdf |
| Michael A. Rutkowski, Chief Operating Officer | mrutkowski@lexamed.net mrutkowski.pdf |
| James P. Kulla, Senior Vice President | jkulla@lexamed.net jkulla.pdf |
| Jim Fisher, Vice President Engineering | jfisher@lexamed.net jfisher.pdf |
| Robert M. Brown, Sr. Consultant, Quality Systems/Operations | rbrown@lexamed.net rbrown.pdf |
| John Huffman, Sr. Consultant, Chemistry/Quality Systems | jhuffman@lexamed.net jhuffman.pdf |
| Carolyn Kinsley, Vice President, Microbiological Compliance | ckinsley@lexamed.net ckinsley.pdf |
| Jim Latham, Sr. Consultant, Microbiology/Quality Systems | jlatham@lexamed.net jlatham.pdf |
| Joseph Mazurek, Vice President, Regulatory and Compliance | jmazurek@lexamed.net jmazurek.pdf |
| Julia Roesner, Director of Information Technologies | jroesner@lexamed.net jroesner.pdf |
| Anne Schuler, Manager, Quality Systems | aschuler@lexamed.net aschuler.pdf |
| Jim Whitcomb, Sr. Consultant, Microbiology/Sterility Assurance | jwhitcomb@lexamed.net jwhitcomb.pdf |
| Dirk Wieringa, Sr. Consultant, Chemistry/Quality Systems | dwieringa@lexamed.net dwieringa.pdf |
| Jemma Williams, Director of Quality Operations | jwilliams@lexamed.net jwilliams.pdf |
LexaMed can also offer 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.
Need a Quick Quote?
Please email your specific request, including name, company name, and desired timeframe to info@lexamed.net.
Quality Validation, Sterilization, Research and Development, and Consulting
©2006
LexaMed, Ltd. All Rights Reserved.
