QbD takes care of your short-term and long-term projects in the field of validation, regulatory affairs, quality assurance and project management & support. We deliver clearly defined results within a specific time frame and budget to our customers.
To optimally support your projects, we make use of a structured approach for project management. After your request, we start with a Quick Scan to gain insight into the specific problem definition, perform a gap analysis and create a CAPA list with critical actions. Based on the Quick Scan, you decide what kind of support you need: coaching or complete project execution.
In the case of coaching, one of our senior experts will support your organization. In addition, you have access to our internal operational resources. If we take care of your whole project, project execution consists of a kick-off meeting, weekly working committees and monthly steering committees. You will be supported by a dedicated team, including a senior project manager and a team of junior engineers.
Our project support can be divided into two main project types: validation and documentation.
Almost every quality control process in the life sciences, healthcare and cosmetics industries contains a certain validation aspect. QbD offers an extensive range of validation services – from cleaning and process validation to validation of analytical methods, warehouses, transport lanes and qualification equipment and facilities. In addition, we closely cooperate with partners to offer services and solutions in complementary areas of specialisation. Read more about our partners for training, software and more.
For organizations launching new products, we offer comprehensive knowledge and expertise in regulatory affairs and its succession. We support organizations in various industries, from pharmaceutics, biotechnology and cosmetics to manufacturers of medical devices or Advanced Therapy Medicinal Products (ATMPs). Our activities include the implementation of Quality Management Systems, preparation of product registration dossiers, supporting ISO certification processes, validation of products and manufacturing processes and more.
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Looking for advice or support for your validation or documentation project?