Regulatory Strategy and Compliance

In vitro diagnostics (IVDs) is a regulated industry in most countries of the world. Strategies for compliance with manufacturing and quality regulations, as well as design and execution of product performance studies is critical to gain the required regulatory approvals. Rx Dx Advisiors can help you:

  • Establish corporate design control and quality systems
  • Work with appropriate regulatory agencies to understand country-specific requirements for product approval
    • Design and execute product verification and validation programs
    • Identify and qualify clinical trial sites
    • Write the product design and performance sections of regulatory submissions
  • Work with your R&D, manufacturing, and quality teams to develop and execute a regulatory compliance strategy
    • Understand the requirements for GMP and ISO13485 certification
    • Create required standard operating procedures (SOPs) for manufacturing and quality
    • Design and execute process validation programs
    • Write the manufacturing and quality sections of regulatory submissions

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