QualityHub is a leading brand that specializes in providing comprehensive auditing services for manufacturers of medical devices, drugs, biologics, and combination products operating in a globally regulated environment. With extensive experience in onsite and remote audits, QualityHub offers a range of audits to meet your company's needs, including Remote Quality Management System Audit, Baseline QMS Audit, Pre-Approval Inspection, Verification Audit, Certification Audit, GMP Audit, QSIT Audit, and more. In addition to auditing, QualityHub also offers staff augmentation services, allowing you to quickly access industry experts and professionals to meet your staffing needs.

They provide temporary staffing for various roles, including Quality, Research & Development, Manufacturing, Supply Chain, Operations, Clinical, and Regulatory Affairs. QualityHub is dedicated to sharing their knowledge and expertise with your company's success in mind. They offer training programs delivered by subject matter experts, covering FDA Inspection Readiness, Quality Management System Training, EU MDR Requirements, Risk Management, and Corrective and Preventive Action (CAPA), among others.

When it comes to FDA regulatory compliance challenges, QualityHub offers guidance and support. Whether your company is facing an FDA 483, Warning Letter, or Consent Decree, their regulatory compliance experts can help create and execute plans to overcome these challenges. They provide strategic project leads, project managers, subject matter experts, and interim quality professionals to ensure compliance throughout the process.

QualityHub also offers assistance in FDA premarket planning and product development. They understand the complexities and time-to-market pressures of new product development and can help with strategic planning, regulatory submissions, independent reviews, and design history file and technical file development. With QualityHub's expertise in risk management, they can help establish and sustain device safety throughout the product lifecycle.

Their team of quality and engineering professionals can assist with risk management program development, risk management file development and remediation, and post-market risk management support. Furthermore, QualityHub specializes in quality management systems consulting. They can guide you in building a clear roadmap for sustainable compliance and continuous improvement.

Their services include the development of QMS compliance/quality plans, QMS development, improvement, and optimization, as well as alignment of quality management systems post-merger/acquisition and for combination products. Overall, QualityHub is a trusted partner in the field of FDA compliance. Their team of FDA compliance consultants, project managers, and medical device regulation experts understand the complexities of the industry and are dedicated to helping your company navigate the regulatory landscape effectively and efficiently.

Contact QualityHub today to benefit from their world-class auditing services and expertise in regulatory compliance