Consulting

Consulting

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.

Expertise

Our team of consultants have expertise in all aspects of medical device and pharmaceutical operations, including, but not limited to:

  • Process and Equipment Validation
  • Sterilization Validation
    • Ethylene Oxide
    • Steam
    • VHP
    • Radiation
    • Dry Heat
    • Notrigen Oxide
  • Aseptic Processing
  • Microbiology
  • Chemistry
    • Method Development
    • Validation
    • Verification
  • Cleanroom Environments
    • Environmental Monitoring
    • Risk Analysis
  • Regulatory Compliance
  • Quality Systems
  • cGMP’s
    • device
    • Pharmaceutical
    • Biologics
    • Medical Gases
  • Compliance Audits
  • GAP Analysis to Regulatory Standards
    • Sterilization
    • Aseptic Operations
    • CAPA and Deviations/OOS
    • Laboratory Operations
    • Supplier Audits

If you would like to discuss your project with one of our experts, please fill out our contact form, and we will be with you immediately.

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