Quality by Design works for lots of big and small pharmaceutical and biotech companies. And although the required fields of expertise are similar in both industries, QbD knows like no other how different both industries are, and that they require a very specific approach.
Read more about our role in the pharmaceutical industry
In the young and highly innovative biotech industry, the development phase of medication and therapies is generally more complex than in the pharmaceutical industry. Also, many of the companies that develop and produce these products are young and small or medium-sized. This poses two major challenges. First of all, unlike the average pharmaceutical giant, they don’t always have the in-house resources and expertise to ensure validation, quality assurance and quality management. It also requires a lot more flexibility: in case of unexpected adversity – for example when the development phase takes much longer than expected – or success, they need to temporarily downsize or upsize accordingly.
QbD’s consultancy offering is the perfect answer to those challenges. By acting as a real partner, rather than just a supplier, we enable biotech companies to grow. From a helicopter view, armed with vast experience in consultancy for the life sciences, we advise on the optimization of our client’s processes. Below, you will find more information on our fields of expertise. But first, let’s have a look at why QbD…
…offers top notch consultancy for a top-notch biotech hub
Flanders, and Belgium as a whole, is one of the most important biotech clusters in the world. One of the reasons for this success is our flexible legislation regarding clinical trials, but without ever losing sight of ethics. Add to that our government’s high investment into research and our abundance of extremely well-educated scientists, and you have the ideal circumstances for biotech companies to innovate and thrive.
This is the climate in which QbD has developed into the reference in consultancy for the biotech industry worldwide.
From our offices in Belgium (HQ), the Netherlands, France, Spain, the United States, Mexico and Colombia, more than 180 QbD consultants help companies that develop and produce therapies to control quality risks during development, production and distribution. We do this by providing consultancy and in-house experts in the following fields:
- Validation and Qualification:
- Equipment Validation
- Cleaning Validation
- Software and Hardware Validation
- Process Validation
- Method Validation
- Computer System Validation
- Quality Assurance (QA outsourcing)
- Regulatory Affairs
- Quality Management
- Quality Management Systems
- Quality Management Software
- Qualified Persons (QP outsourcing)
- Project Management & Support
- Tech Transfer
Want to know more about what QbD can do for you?