Your life sciences partner throughout the entire product lifecycle

The QbD Group supports life sciences companies worldwide from idea to patient.

our services

Our Services

EXPERT DOMAINS

QbD’s team offers knowledge & tailored (software) solutions in development, clinical, regulatory & compliance, production and distribution for companies active in ATMP, Biotech, Medical Devices, In Vitro Diagnostics, Digital Health and Pharma.

Our services

Regulatory Affairs

We help our clients in their journey throughout the entire drug and medical device regulatory lifecycle.

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Clinical

We are an expert clinical solutions provider specialized in medical devices and biotech, offering global CRO services and consultancy.


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Qualification & Validation

We guarantee that products meet quality demands and comply with regulations through the qualification and validation of your equipment, facilities, and process support.

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Quality Assurance

We offer the full range of QA services necessary to get your product to market in a safe and compliant way, including auditing from certified auditors, setting up your QMS, and all QP activities.

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Quality Control

Our QC division consists of a GMP laboratory that offers analytical services for testing pharmaceutical raw materials, excipients, and release testing of finished products.

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Software Solutions & Services

Our solutions include a cloud-based and pre-validated QMS built for the life sciences, as well as eIFU services which enable IVD and MD manufacturers to digitalize paper Instructions For Use. 

Our range of services include Computer System Validation and Digital Health services.

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Go to market

We help you launch your product to market by providing marketing and communication services, business development support and sales strategy.

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We support companies in life sciences

SECTOR FOCUS

Since 2011, QbD has been providing quality solutions for productdevelopmentandmanufacturing. 

The QbDGroup’s team offersthe skills and expertise for solving complex problems for companies active inthe life sciences.

Select your industry

Advanced therapy medicinal products

Medical Devices

In Vitro Diagnostics

Digital Health

Small molecules & generics

Biotech

Industries we cover

EXPERT KNOWLEDGE

Medical Devices

All classes

Implantables

In Vitro Diagnostics

Digital Health

All other devices

Medicinal Products

Small Molecules

Biotech

ATMP

Select your industry

We make quality management easy

QUALITY MANAGEMENT SOFTWARE

The first cloud-based and pre-validated Quality Management Software built for Life Sciences. Writing down your quality processes is one thing, but making sure everybody is aware of them and following-up on events, CAPAs and a plethora of related actions is what keeps QA people awake at night. With Scilife you can reclaim your peaceful nights again.

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We support your full project in a flexible way

WAY OF WORKING

We work with a risk-based, project plan approach, focusing on what’s really important:

increased efficiencyreduced workloadreduced total compliance costsguaranteed optimal quality, safety and compliance of products

Our project plans and services vary from short-term and long-term consultancy to a Quick Scan, taking care of complete projects or working together according to our unique Academy Model.

Our approach

Featured expertise

OUR FOCAL POINTS

Within our three focal points – ATMPs,  Medical Devices and Digital Health, we take on a pioneering role on a global level and help determine the rules in these two fields.

ATMPs

Medical Devices

Digital Health

ATMPS AREA REALITY

They are revolutionizing healthcare by introducinghighly effective treatments for various diseases.

Who is the QbD Group?

OUR COMPANY

By bringing our consultants and their expertise together with our life sciences clients in the best possible way, we help our clients to develop safe therapies and technologies for patients and consumers.

We do this worldwide, with over 450 people who are highly qualified in regulatory affairs, clinical, qualification & validation, quality assurance, quality control, software services & solutions and go to market.

To this end, we have set up offices including Belgium (HQ), the Netherlands, France, Switzerland, Spain, Mexico, and Colombia.

Join our teamPlay Video about Quality by Design (QbD) becomes QbD Group, consolidating its offerings to support the development of innovative life science products, “from idea to patient”

Latest company news

QBD GROUP NEWS

The QbD Group appoints new COO and Senior Director Integration to further align the Group’s international activities and acquisition integration processes

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QbD Group requalifies as Best Managed Company

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TRIUM Clinical Consulting is being rebranded to QbD Clinical

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Quality by Design (QbD) becomes QbD Group

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QbD acquires marketing & communication agency ‘Monkeys not Donkeys’ to strengthen its services within the life science industry.

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New office and strengthened team for QbD Wallonia

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Latest blog posts

LIFE SCIENCES INSIGHTS

Team up with a Contract Research Organization (CRO) dedicated to medical devices to boost your clinical research strategy

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Finding your way through the maze of international, European, and harmonized standards for medical devices

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AI and machine learning validation: strategies and examples

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What is the purpose of Periodic Reviews in CSV?

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The importance of high-quality gas distribution networks for critical process gases, even in the early development phase

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New edition of the GAMP 5 guide ‘A Risk-Based Approach to compliant GxP Computerized Systems’ expected in 2022

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WE WORK, WE PLAY, WE DELIVER

We are Quality by Design0offices worldwide0+employees0+happy clients0+successful projects

Global reach with a local presence

INTERNATIONAL PROJECTS

QbD is an international organization. Not only because of its offices across the globe (Belgium, the Netherlands, Spain, France, Mexico, Colombia, and many more), but its global network enables QbD also to execute projects in many places.

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Whitepapers

We are happy to share our knowledge with you via free to download content pieces.

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