LexaMed provides regulatory compliance consulting services for clients from the pharmaceutical, medical device and nutritional supplement companies. LexaMed can assist in all areas of medical device, pharmaceutical and related industry compliance activities, including consulting on compliance and remediation action plans and strategies, assisting in new product submissions and registrations – FDA, EPA, EU, Canada Medical Device Regulations (MDR), Australia TGA, Brazil Anvisa, and conducting compliance audits against CFR 820, 210/211, 111, ISO 13485, 17025, Q7A, etc. LexaMed can also generate data in our ISO 13485 certified laboratory to support product submissions.

Robert Dean

Robert Dean

Senior Consultant, Regulatory Affairs

Robert Dean is our resident subject matter expert in regulatory assistance. Download his Curriculum Vitae above for his experience. If you would like a quote for regulatory consulting, please submit your request to info@lexamed.net.

  • CAP Execution: Consulting
  • Prepares 483 Observation responses and warning letter responses
    Structures Compliance Action Plans
    Experience with consent decree and CAP
    management
    Experience interacting with FDA
    Integrates program with client resulting in internal
    sustainability
  • CAP Execution: Laboratory Support
  • ISO certified laboratory operation supports CAP remediation efforts:
    Microbiology/Chemistry
    Packaging
    D-value and z-value determinations
    Disinfectant Efficacy and Antimicrobial
    Effectiveness Testing
    Microbial Limits
    Container Closure Integrity (CCI)
    Customized projects

  • CAP Execution: Consulting
  • Teams of experienced consultants can address any situation with technically competent, proactive and comprehensive solutions in:
    Validation
    Sterilization
    Microbiology & Chemistry
    Environmental Monitoring
    Training
    Audits
    Quality Management Systems
    Regulatory Affairs
  • CAP Sustainability: Effectiveness Program
  • Designed for disciplined decision making and resource
    focusing
    Defines Key Performance Indicators (KPI)
    Manages organizational change
    Assesses CAPA effectiveness
    Establishes process capabilities