Deployed in a flexible and cost-effective approach, our highly experienced experts are available to supplement your organization’s efforts, address an immediate business issue or a regulatory challenge, or provide assistance during periods of organizational transition.
Our Rent a Lean Six Sigma Black Belt program brings the benefits of Lean Six Sigma to your organization right away. Our Black Belts and Master Black Belts have years of industry experience that can help accelerate deployment of Six Sigma skills when you have a pressing need that requires immediate action. Many of our customers choose to rent a Black Belt to lead projects while their associates are being developed. Whether you have a specific problem to be solved immediately or a general need to improve your business processes, our Black Belts can fill in the gaps.
Our Lean Six Sigma Black Belts can help:
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Provide immediate Lean Six Sigma assistance to accelerate results.
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Leverage years of industry experience as we partner with you for specific projects.
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Lead projects teams, allowing for us to develop and guide the development of your employees.
Our Rent an FDA Expert program helps you to manage and sustain FDA-related quality, regulatory, or compliance protocols.
Our FDA experts can help when you need to:
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Develop and execute U.S. and international regulatory strategies.
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Prepare 510(k), technical file, and product registration documentation for regulatory submission and worldwide product registration.
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Have expert quality and/or regulatory guidance on project teams.
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Ensure consistency, completeness, and adherence of standards for FDA submissions.
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Establish and maintain relationships with regulatory agencies, including U.S., foreign, and selected registrars or notified bodies.
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Facilitate regulatory compliance to applicable requirements, such as ISO 13485, FDA GMP, and quality system specifications.
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Conduct risk assessment and assist in the implementation of actions to mitigate them.
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Plan, design, and deliver training programs, including evaluations of their effectiveness.
Our FDA experts:
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Have thorough knowledge of the quality, regulatory, and compliance functions throughout the product life cycle in a broad range of areas, such as:
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Biologics
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In vitro diagnostics
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Medical devices
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Pharmaceuticals
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Are familiar with both U.S. and global regulatory and compliance requirements.
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Have extensive experience in the field.
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Can determine the significance of quality, regulatory, or compliance issues and formulate corrective and preventive action plans to deal with them.