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White Papers

  • All
  • Medicinal Products
  • Medical Devices
  • Freyr Digital
  • Growing Importance of Metadata in Regulatory Submissions
     March 21, 2025
     
    Medicinal Products, 
    Publishing and Submission
    Growing Importance of Metadata in Regulatory Submissions
  • Aligning Supplier Evaluation Practices with 21 CFR 820 and ISO 13485 Requirements
     March 20, 2025
     
    Medical Devices, 
    Quality, Compliance, & Audit (QMS)
    Aligning Supplier Evaluation Practices with 21 CFR 820 and ISO 13485 Requirements
  • Navigating Packaging Artwork Compliance in the Life Sciences Industry
     February 14, 2025
     
    Medicinal Products, 
    Artwork
    Navigating Packaging Artwork Compliance in the Life Sciences Industry
  • Accelerating Validation Processes in Pharmaceuticals: AI and Automation for Quality and Compliance
     December 5, 2024
     
    Medicinal Products, 
    Compliance and Audit Services
    Accelerating Validation Processes in Pharmaceuticals: AI and Automation for Quality and Compliance
  • Comprehensive Guide to UAE Cosmetics Regulations
     December 4, 2024
      Cosmetics
    Comprehensive Guide to UAE Cosmetics Regulations
  • Exploring GenAI Model Training and Fine-Tuning in Production
     December 2, 2024
      Freyr Digital
    Exploring GenAI Model Training and Fine-Tuning in Production
  • Trial Master File (TMF): Its impact before and after EU CTR Regulation
     November 11, 2024
     
    Medicinal Products, 
    Regulatory Affairs
    Trial Master File (TMF): Its impact before and after EU CTR Regulation
  • Strengthening Regulatory Product Registration in Developed Markets
     September 16, 2024
     
    Medicinal Products, 
    Publishing and Submission
    Strengthening Regulatory Product Registration in Developed Markets
  • Significance of Abuse Liability Assessment in the Medical Writing Arena
     August 27, 2024
     
    Medicinal Products, 
    Medical Writing
    Significance of Abuse Liability Assessment in the Medical Writing Arena
  • Strategic Consulting for Early Approval of Medicinal Products in Japan: Utilizing Foreign Clinical Data and PMDA Consultation
     August 20, 2024
     
    Medicinal Products, 
    Regulatory Affairs
    Strategic Consulting for Early Approval of Medicinal Products in Japan: Utilizing Foreign Clinical Data and PMDA Consultation
  • how-to-navigate-when-clinical-data-is-not-deemed-appropriate
     August 7, 2024
     
    Medical Devices, 
    Clinical & Performance Evaluation
    How to Navigate EU MDR Article 61(10)? When Clinical Data is Not Deemed Appropriate
  • Medical Devices Regulatory Landscape in Japan: A Comprehensive Guide
     August 7, 2024
     
    Medical Devices, 
    Regulatory Affairs
    Medical Devices Regulatory Landscape in Japan: A Comprehensive Guide

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