案例研究 | QbD Group

2026年2月3日 2 分钟

GMP Support for Closing CAPAs Across Quality Assurance, Qualification & Validation, and Software

Learn how QbD Group helped a biotech CDMO close CAPAs across Quality Assurance, Qualification & Validation, and Software, strengthening GMP compliance and audit readiness.

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Multiplex Respiratory Antigen Test: Accelerating IVDR Market Access

Clinical2025年8月19日 2 分钟

Fast-track your IVDR market access with our expertise. We help clients navigate regulatory hurdles to launch innovative diagnostic solutions efficiently and effectively.

Building a Unified QMS for a Non-Profit Lab Organization

Software Solutions & Services2025年8月6日 2 分钟

A non-profit lab organization unified its quality management processes by implementing a validated SAAS QMS, enhancing compliance and efficiency across departments.

Agile Validation Support for a Global Life Sciences Organization

Software Solutions & Services2025年8月6日 2 分钟

Discover agile validation support for life sciences, enhancing compliance and efficiency through a scalable, on-demand model tailored to your IT validation needs.

Faster Market Entry Through Integrated IVDR and WHO Strategy

Clinical2025年8月5日 1 分钟

Accelerate your market entry with our integrated IVDR and WHO strategy, ensuring compliance while minimizing costs and sample size for diagnostic tests.

Multiplex STI PCR Test: Supporting a Smooth IVDR Journey

Clinical2025年7月29日 2 分钟

Learn how we supported a global IVD manufacturer in achieving IVDR compliance for their multiplex STI PCR test, ensuring timely CE-marking and future regulatory confidence.

Validating a Complex Autoclave Load to Enhance Sterilization Efficiency

Qualification & Validation2025年5月28日 2 分钟

Discover how QbD Group helped a pharmaceutical facility in Barcelona optimize and validate a complex autoclave load, improving sterilization efficiency and manufacturing flexibility.

Fast-Tracked Site Qualification for Clinical Trial Submission

Clinical2025年5月21日 3 分钟

QbD Group helped a biotech company complete 5 site qualification visits in just 3 weeks enabling a timely and compliant clinical trial submission.

Enhancing data integrity & aseptic manufacturing compliance

Quality Assurance2025年4月7日 2 分钟

QbD Group helped a leading medical tech company improve MDR compliance and enhance aseptic manufacturing for long-term regulatory readiness.

A Decade of Excellence: Linguistic Review Support for a Global Pharma Leader

Regulatory Affairs2025年4月1日 2 分钟

QbD Group streamlines linguistic reviews for a leading pharma client, ensuring compliance and accuracy across 25 EU/EEA languages while meeting stringent regulatory deadlines.

Restoring manufacturing timelines through expert deviation management

Quality Assurance2025年3月5日 2 分钟

Discover how QbD Group helped a leading biotechnology company overcome a backlog of deviations, restoring timely batch release through expert QA support.

Supporting Market Access to Essential Medicines in Europe

Regulatory Affairs2025年3月5日 2 分钟

Support your entry into the European pharmaceutical market with expert regulatory guidance, ensuring compliance and access to essential medicines for patients. Contact us today for assistance.

Scalable MSAT validation support for seamless compliance & efficiency

Qualification & Validation2025年3月5日 2 分钟

Discover how QbD Group helped a global pharmaceutical company address fluctuating validation demands across multiple teams.