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.

Our concept of project management involves the integration of individuals with varied skill-sets into multi-functional 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
    • Nitrogen Dioxide
  • 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
    • Aseptic Operations
    • CAPA and Deviations/OOS
    • Laboratory Operations
    • Supplier Audits

Meet LexaMed’s Team of Experts

Robert Reich

Robert Reich

President

Robert Reich is a microbiologist with over 40 years of experience in the healthcare industry in the areas of Management, Validation, Quality and Regulatory Affairs. He has been as a member of task groups drafting guidelines on biological and chemical indicators, bioburden quantitation and microbiological methods for the assessment of packaging integrity.
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James Kulla

James Kulla

Senior Vice President

Jim has been active in the medical products industry since 1967. Jim founded a company in 1980 that offered contract laboratory services and contract sterilization to the medical device and pharmaceutical industries and assembled and packaged custom surgical packs and private label medical devices. In addition, Jim has experience with vendor audits and quality systems. He has developed programs for the chemical analysis of drug substances and the review of new products for EO and gamma sterilization.
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Anne Schuler

Anne Schuler

Director, Quality Operations

Anne has over 25 years of technical/quality/regulatory experience within the medical device industry. She has a strong background in quality control, domestic and international regulatory compliance, customer service, project management, internal and external consultation and document preparation. Furthermore, she possesses additional strengths in organizational skills, problem solving and quality system management.
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David Brodersen

David Brodersen

Director, Technical Services/Strategic Initiatives

David is a results-oriented Global Quality leader who combines strategic thinking and business knowledge to achieve organizational improvements. He has proven success in leading high-performance organizations and cross-functional cooperative initiatives to develop quality solutions and strategies to achieve stated objectives and goals. He is a leader in Strategic Planning, Analysis and Execution with a proven ability to act as a change agent and lead organizations through change management.
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James Latham

James Latham

Sr. Consultant, Microbiology/Quality Systems

James is a microbiologist who has over 20 years of technical experience in the medical device, pharmaceutical and biotechnology industries. He is experienced in process and cleaning validations, the calibration of spectrophotometric, clean room qualifications, electrochemical and thermal sensors/systems. He also has expertise in IQ, OQ and PQ for sterilization equipment which includes barrier technology and SIP systems.
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Xiao-qun Zeng, SM (NRCM)

Xiao-qun Zeng, SM (NRCM)

Project Team Lead

Xiao is a project team lead with more than 20 years of technical experience in biotechnology, pharmaceutical and medical device industries. She has extensive experience in development of methods and techniques, management of R&D projects, and assessment of microbiological laboratory procedures. She has successfully generated and executed numerous client-specific protocols in compliance with ISO, USP, AAMI, AOAC, and ASTM standards and guidelines.
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John Huffman

John Huffman

Sr. Consultant, Chemistry/Quality Systems

John has over 30 years of experience in the pharmaceutical and medical device industry focusing on analytical chemistry, methods development and validation, stability programs, medical device packaging, and regulatory compliance. Regulatory compliance included coordination of failure, complaint, and OOS investigations and implementation of associated CAPA programs as well as preparation of responses to FDA 483 observations. He has organized and directed both chemistry and microbiology laboratory operations.
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Ramon Burns, Ph.D.

Ramon Burns, Ph.D.

Sr. Consultant, Chemistry

Ramon has over thirty years of experience providing expertise in pharmaceutical sciences in the biopharmaceutical and medical devices industries. He is a six-sigma black belt and has an impressive thirteen patents as well as over twenty publications or published meeting abstracts. Specifically he has actively worked on and/or led consulting projects in the following areas: biologics, pharmaceuticals, and medical devices. Ramon provides consulting services for clients from pharmaceutical and medical device companies.
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Carolyn Kinsley

Carolyn Kinsley

Vice President, Microbiological Compliance

Carolyn has been active in the medical products industry since 1976. Her vast experience includes the manufacture, quality control and sterilization of medical devices and pharmaceuticals, biological indicator performance, and monitoring environmental microbial profiles in medical device/pharmaceutical manufacturing facilities, including aseptic filling operations.
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Robert Dean

Robert Dean

Sr. Consultant, Regulatory Affairs

Robert has over 35 years of experience providing expertise in all facets of sterile medical device, pharmaceutical, bio-technology, infection control operations, including regulatory affairs, quality assurance, engineering, lean manufacturing / planning, materials / MRP, MIS, and, sales, providing for a strong ability and energy to contribute and channel an organization to accomplish extraordinary objectives. Robert has strong focus and capabilities in accomplishing corporate visions, focus and leadership providing measured management and accountability.
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Philip Schneider

Philip Schneider

Sr. Consultant, Microbiology/Quality Systems

Philip is a Microbiologist with over 40 years of professional experience in the health care industry including 31 years with 3M Health Care. He has work experience in the areas of medical device manufacturing, product development, quality assurance, regulatory affairs and customer support in both health care facility and industrial applications. He is presently Co-Chair of both the ANSI/AAMI Biological Indicator and the Ethylene Oxide Hospital Practices Working Groups. He has also been involved in numerous other working groups during his 17 years in the ANSI/AAMI organization. Additionally, he is the Convener of the ISO/TC 198 Biological Indicator Working Group 4.
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Jeff Martin

Jeff Martin

Sr. Consultant, Sterilization/Quality Systems

Jeff currently stands as the co-chair for the AAMI Industrial EO Standards working group. Jeff is a quality subject matter expert with national and international industry recognition serving for over twenty years in device and pharmaceutical industry in terminal sterilization, Quality Systems and operations. Jeff is an active member in multiple AAMI working groups for the development and review of US standards for validation, control and routine monitoring.

Jeff is a leader and mentor for validation personnel in performance of sterilization and microbiology efforts across a diverse pharmaceutical and medical device industries.

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Marcus Keller

Marcus Keller

Project Manager

Marcus is a graduate microbiologist and is our subject matter expert in the following fields: steam sterilizations of reusable medical devices, container closure integrity testing (CCI and CCIT), and validations of filter sterilization of liquids.
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Kelly Fahrbach

Kelly Fahrbach

Project Manager

Kelly is in her eighth year of skilled microbiology and chemistry laboratory experience in the pharmaceutical and medical device industries; focusing on bioburden and sterility assurance testing, limulus amebocyte lysate (LAL) testing for detection and quantification of bacterial endotoxin on medical devices, and environmental monitoring. She has experience in laboratory settings, including basic chemistry and microbiology laboratories, basic microbial techniques and identification of microbes, and executing proper sterile technique. She is the in-house cleaning and disinfection validations of reusable devices subject matter expert (SME).
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Erin Huber

Erin Huber

Project Manager

Erin is in her ninth year of skilled microbiology and chemistry laboratory experience in the pharmaceutical and medical device industries, focusing on project management. Her projects include accelerated aging, antimicrobial material testing, sterilization validations, and establishing environmental monitoring programs. She has experience in laboratory settings, including basic chemistry and microbiology laboratories, microbial techniques and identification of microbes, and executing proper sterile technique. Erin is the in-house subject matter expert (SME) of antimicrobial material testing.
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Need a Quick Quote?

Please email your specific request, including name, company name, and desired time frame to info@lexamed.net.

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.