As a quality-driven organization, we care a lot about quality and compliance. As part of our quality commitment, TRIUM is now a proud member of the QbD group.
Since 2011, QbD has been helping companies in the life sciences industry to qualitatively develop advanced therapies & technologies for the benefit of patients & consumers worldwide. QbD offers companies specialized knowledge, expertise and software in the field of quality management, regulatory, validation and tech transfer. With more than 275 experts, the QbD group 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.Read more
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.Read more
QbD 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.Read more
Project Management & Support
Quality and flexibility are key in how QbD gets things done. With more than 275 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.Read more
Production systems for the pharmaceutical and food industries have to comply with ever-stricter legislation, including regulations of the European Medicine Agency (EMA) and Food & Drug Administration (FDA). Although Good Automated Manufacturing Practice (GAMP) is not a mandatory legislation, it provides important guidelines for companies involved in the development and/or implementation of automated systems. Let’s explain GAMP 5®.Read more
TRIUM offers a wide range of services to validate the quality of your clinical trail. It all starts with the setup of the entire clinical QMS(cQMS) in addition to your overall QMS system, but could include separate parts as well, including clinical SOP development and risk based management. During the execution of a trail, TRIUM supports you with preparation of inspections, auditing of sites, sponsors or vendors, and follow-up of inspections and audits through root cause analysis and CAPA. Training and advise related to ICH-GCP, ISP and Good Documentation Practises are part of the service portfolio.Read more