Since 2011, QbD has been helping companies in the life sciences, healthcare, and cosmetics industries to qualitatively develop and produce products. QbD offers companies specialized knowledge, expertise, and software in the fields of validation, quality assurance, regulatory affairs, and project management & support. With more than 200 quality experts, QbD is your partner for advice and support on controlling quality risks.
Validation
QbD offers an extensive range of validation services for your processes, applications, and equipment. Our specialists work in an efficient and well-structured way. Our risk-based approach guarantees the right focus, ensuring that your biotech products meet high-quality standards and comply with regulations. This proves that they are correctly prepared, packaged, labeled, and traceable.
Quality Assurance
QbD provides all QA activities necessary to bring your product to market in a safe and compliant manner. We establish, implement, and train all required procedures to shape your Quality Management System in a compliant and efficient way. We know how to tackle any highly regulated supply chain demand and even offer QP/RP services in a flexible and tailor-made manner. QbD truly assures quality in a compliant way without losing sight of efficiency and added value.
Regulatory Affairs
QbD supports you throughout the entire drug and medical device regulatory lifecycle. This includes Regulatory Compliance, Artwork & Labeling, eCTD Submissions, Market Authorization, Investigational Fillings, Document Services, and Regulatory Dossiers. QbD can insource full regulatory affairs projects in an efficient and pragmatic manner, resulting in paper-based or fully electronic product submissions that are effectively managed and compliant with applicable legislation.
Project Management & Support
Quality and flexibility are key to how QbD gets things done. With more than 200 professional quality consultants worldwide, QbD manages and supports any QA, validation, or regulatory project from A to Z. Our broad scientific and professional expertise gives us the flexibility to adapt our approach to the project pace you desire, considering your in-house resources and budgets. When necessary, QbD easily scales up or down the effort to successfully execute the project. To all this, we add transparent reporting through monthly steering committees and weekly working committees.
