Your life sciences partner throughout the entire product lifecycle.

QbD supports companies worldwide in the life sciences throughout the entire product lifecycle, from idea to patient.

Expertise & Solutions

Our Services

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

Clinical Solutions

We offer a unique combination of global CRO services, consultancy and quality & compliance services.

Regulatory Affairs

We support you throughout the entire drug or medical device regulatory lifecycles.

Validation & Qualification

We guarantee that your products meet quality demands and comply with regulations.

Quality Assurance

Ensuring quality of products and services is a challenging venture for many companies.

Quality Control

We offer analytical services for testing pharmaceutical raw materials, excipients, and release testing of finished products.

Project Management

Full-service partner in project management and support in the field of quality management.

Software solutions

The first cloud-based and pre-validated Quality Management Software built for life sciences. 

Training

We offer training and coaching for companies, small groups and individuals.

Industry focus

We support companies in life sciences

Since 2011, QbD has been helping companies in the life sciences and healthcare industry 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.

Quality Management Software

We make quality management easy

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.

way of working

We support your full project in a flexible way

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

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.

The Medical Devices and In Vitro Diagnostics industry is subject to an ever-increasing complexity. We're here to help!

Featured expertise

Medical Devices & ATMPs

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

Medical Devices &
In Vitro Diagnostics

The manufacturing and validation of MDs and IVDs entail a wide variety of challenges. We are more than happy to support you.

Advanced Therapy Medicinal Products

We help you resolve the abundant challenges currently faced in the development and production of a new ATMP.

ATMPs are a reality. They are revolutionizing healthcare by introducing highly effective treatments for various diseases.

Our company

Who is Quality by Design?

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 300 people who are highly qualified in QA, validation, regulatory affairs and project management & support in the pharmaceutical, biotech, healthcare and medical devices.

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

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We work, we play, we deliver

We are Quality by Design

international projects

Global reach with a local presence

QbD is an international organization. Not only because of its offices in 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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Successful Projects

IVDR 2017/746 - How to prepare for compliance?

MDR 2017/745: a brief introduction

Checklist MDR implementation

Checklist ISO13485