Quality by Design (QbD)

Address : Fotografielaan, 5 - 2610 Wilrijk
Website : qbd.eu
Contact person : Simon DERE

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. 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.

Quality Assurance

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.

Regulatory Affairs

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 200 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.