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Staff Augmentation/ Rent an FDA Expert

Oriel STAT A MATRIX’s Staff Augmentation/Rent an FDA Expert program is designed to address fluctuating resource capability or capacity so you can manage and sustain FDA-related quality, regulatory, and/or compliance protocols.

How We Help

Deployed in a flexible and cost-effective approach, our highly experienced Medical Device Regulatory and Quality Assurance experts are available to supplement your organization’s efforts, address an immediate regulatory challenge, or provide assistance during periods of organizational transition.

Our FDA experts can help when you need to:

  • Facilitate global regulatory compliance to applicable requirements and standards, such as ISO 13485, FDA GMP, and other quality system specifications.
  • Prepare a global regulatory strategy, 510(k) or PMA submission, STED application, design dossier/technical file, and other product registration documentation for regulatory submission and worldwide product registration.
  • Obtain independent expert quality and/or regulatory guidance on project teams in commonly known problem areas within a Quality System, such as CAPA, Complaint Handling, Design Controls, and Supplier Quality – or when you require assistance with recalls.
  • Mitigate serious Quality System deficiencies, including development and implementation of corrective action plans to address 483 observations, warning letters, or consent decrees.
  • Ensure consistency, completeness, and adherence to standards for FDA submissions.
  • Establish and maintain relationships with regulatory agencies, including US, international, and selected registrars or Notified Bodies.
  • Conduct gap analysis and/or risk assessment and take actions to mitigate risks that have been identified.
  • Plan, design, and deliver training programs, including evaluating their effectiveness.
  • Audit your Quality Management System or a supplier’s Quality System.
  • Ensure that you’re prepared and ready for an FDA inspection or an audit.

Our FDA experts:

  • Have an average of 25+ years of life sciences industry experience.
  • Possess thorough knowledge of the quality, regulatory, and compliance functions throughout the product life cycle in a broad range of areas, such as:
    • Biologics
    • In vitro diagnostics
    • Medical devices
    • Pharmaceuticals
  • Are familiar with both U.S. and global regulatory and compliance requirements.
  • Have extensive experience in the field.
  • Can determine the significance of quality, regulatory, and/or compliance issues and formulate corrective and preventive action plans to deal with them.

 

Provided below are a variety of practice related white papers, market updates and case studies.

Bolster Your In-House Resources with Staff Augmentation from Oriel STAT A MATRIX

Our team is here to help. Call 1.888.532.6360 or contact us online ›