Combination Products

Navigating the evolving, complex sea of regulations for Combination Products can be confusing and leave you with uncertainties. Strategic product development, coupled with an effective regulatory submission framework, increases the likelihood of a successful and timely launch of Combination Products.

Understanding the Rules for Combination Products

The rules for Current Good Manufacturing Practice (cGMP) Requirements for Combination Products were issued by the FDA in 2013. Existing Quality Systems can stay in place, but new requirements are necessary for the components not already addressed. This is where Regulatory Compliance Associates® can support your team in various scenarios:

When adding a Device to Existing Drug or Biologic Product:

  • Design controls apply when a device constituent part is used in a combination product
  • Corrective and Preventive Actions (CAPA) process required
  • Management responsibility must be clearly identified

When adding a Drug or Biologic to a Device Product:

  • Need incoming materials and Release Testing
  • Expiration Dating and Stability Testing are required
  • Calculation of Yield must be included
  • Component, container-closure, and tamper-evident requirements are added

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    Support for your Combination Products

    Whole Product Lifecycle Support

    Regulatory Compliance Associates® has the expertise to see you through the entire lifecycle of your Combination Products. Count on us to support you with:

    • Design and Development File (component selection, assembly,  production controls, through design verification and validation)
    • Product Assessment and Request for Designation (RFD Submissions)
    • Global Regulatory Strategies (including Notified Body Opinions for CE under MDR)
    • Agency Briefing Packages and Meeting Execution
    • Chemistry, Manufacturing, and Controls (CMC) and Clinical Data Support
    • Quality Systems Development and Support
    • Product Submissions (NDA, IND, ANDA, BLA, IND, 510(k), and PMA)
    • Electronic Common Technical Document (eCTD) Publishing and Electronic Submission
    • Inspectional Readiness
    • Training for Modified Quality Systems
    • Life Cycle Management and Post Approval Support
    • Due Diligence Audits / Mergers and Acquisitions
    Strategic eight-step Regulatory Plan

    Regulatory Compliance Associates® has developed an eight-step strategic regulatory plan for Combination Products:

    1. Define the Combination Product / Constituent Parts / Primary Mode of Action (PMOA)
    2. Prepare a Preliminary Regulatory Strategy
    3. Submit a Pre-Request for Designation (Pre-RFD)
    4. Update the Regulatory Strategy based on FDA’s Preliminary Informal, Non-Binding Designation
    5. Submit a Request for Designation (RFD)
    6. Update the Regulatory Strategy based on FDA’s Formal, Binding Designation Letter
    7. Early Collaboration Meeting with Lead Agency Center / Pre-Submission (PreSub) Meeting
    8. Submit Marketing Application(s) to Lead Agency Center

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