Regulatory Assistance

Regulatory Assistance

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.

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 Execution: Effectiveness Program

  • Designed for disciplined decision making and resource focusing
  • Defines Key Performance Indicators (KPI)
  • Manages organizational change
  • Assesses CAPA effectiveness
  • Establishes process capabilities

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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