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 180 quality experts, QbD is your partner for advice and support on controlling quality risks.
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. This way, you can guarantee that your biotech products meet the high quality demands and comply with regulations, and prove that they are correctly prepared, packaged, labelled and traceable.
QbD offers all QA activities necessary to get your product to the market in a safe and compliant way. We set up, implement and train all necessary procedures to shape your Quality Management System in a compliant and efficient way. We know how to tackle any highly regulated supply chain demand. We even provide QP/RP services in a flexible and tailor made way. QbD really assures quality in a compliant way without losing efficiency and added value out of sight.
Quality by Design helps you in your journey throughout the entire drug and medical device regulatory lifecycle. This includes Regulatory Compliance, Artwork & Labelling, eCTD Submissions, Market Authorization, Investigational Fillings, Document Services and Regulatory Dossier. QbD is able to insource full regulatory affairs projects in an efficient and pragmatic way. Resulting in paper based or fully electronic product submissions that are efficiently managed and compliant with the applicable legislation.
Project Management & Support
Quality and flexibility are key in how QbD gets things done. With more than 180 professional quality consultants worldwide, QbD will manage and/or support 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 that you desire, taking into account your available in-house resources and budgets. When necessary, QbD easily scales up or down the effort when needed to successfully execute the project. To all this we add transparent reporting via monthly steering committees and weekly working committees.
Our Focal Points
Medical Devices are subject to an ever-increasing number of standards, like ISO 13485. Ensuring their quality, safety and efficacy requires a tailored Quality Management System. QbD offers a wide range of solutions to make sure the production and validation of medical devices are on the right track from day one.
Advanced therapy medicinal products are becoming a reality, and they will soon revolutionize the biotech industry. But what are ATMPs exactly? Which opportunities does it have to offer to biotech companies and which pitfalls and regulations will you have to consider when adopting this innovation? QbD is your ATMP expert.