Quality Solutions

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 300 experts, the QbD group is your partner for advice and support on controlling quality risks.

Our services

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

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.

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.

GAMP 5®

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®.

Clinical Quality

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 as part of 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 Practices are part of the service portfolio.

GDPR

Data protection is key when collecting trial subject information. TRIUM helps companies to set up their general policies and documentation to cover all GDPR requirements, including those related to the successful execution of your clinical trail.

Can we help you?

Every company is different and has specific quality needs. We listen to you and provide a tailored approach. Don’t hesitate to contact us if you would like to share thoughts on your quality processes and how we can help you. Contact us

Why TRIUM?

Our Strength

Dedicated subject matter experts
Quality strategies and business integration
Services tailored to client needs
Pragmatism

Your win

Create a tailored quality structure
Workable procedures and policies
Quality metrics, KPIs and drivers
Audit and inspection ready

Our other expertises

TRIUM, part of the QbD group, is an expert clinical solutions provider specialized in medical devices and biotech. We offer a unique combination of global CRO services, consultancy, clinical quality services and training.