QualityHub comprises a top-ranked team of FDA compliance consultants, project managers and medical device regulation experts that know what your company needs in the complex field.
QualityHub has extensive experience in performing onsite and remote audits for medical device, drug, biologic, and combination product manufacturers who operate in a globally regulated environment.
Whatever your staffing needs may be, QualityHub can quickly mobilize the right balance of industry expertise and skills to deliver immediate results.
QualityHub has subject matter experts with demonstrated excellence in speaking, training and conducting educational workshops. Our passion for learning inspires our trainings and allows us to develop personalized workshops and training experiences that will best fit your company’s culture and environment.
Whether your company is facing an FDA 483, Warning Letter or Consent Decree, QualityHub can help your leadership team create and execute the plans to overcome your company’s FDA regulatory compliance challenges.
Finding your gaps is just the beginning. QualityHub’s FDA regulatory compliance experts can help you accomplish the work needed to bring your organization into compliance.
We can provide the needed quality system project (strategic) leads, project managers, and subject matter experts who can help guide, coach and move the critical project along.
For more tactical work, our associate consultants can help execute on quality system deliverables and documents. Our interim quality professionals solution can provide interim management and other personnel to ensure the work continues throughout the process of addressing your FDA 483, Warning Letter or Consent Decree.
QualityHub understands the challenges of new product development and obtaining regulatory approvals in a competitive environment where time-to-market matters.
Effective risk management requires a beginning-to-end approach to establishing, supporting and sustaining device safety throughout the product lifecycle.
QualityHub will guide you through the development of a clear roadmap to build the foundation for sustainable compliance and continuous improvement.
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