Fields of Work
QBDC stands on three thematic pillars, Quality, Development, and Production.
Whether the scope of our client be Biosimilars, NBEs, tissue engineering, or other (bio-)medicinal products, whether it be USP, DSP, or Fill&Finish, or whether it be audits, GMP compliance, or SOPs, most of them touch two or even all three of said pillars, and can seldom be approached individually.
With our holistic approach, we always work on the big picture.
The following list shows a selection of our favoured fields of work:
- Fill & Finish
- Quality Management
- Quality Assurance
- Project Management
- Process Development & Optimization
- Facility Layout & Design
- GMP/cGMP Compliance
- Data & File Management
- Risk Management
- Cost Calculations
A detailed company track record is available for download (QBDC Info [pdf]).
Services are our main products. They are unique for every client and, thus, we tailor them to your desires and align them with all relevant factors such as country of production, target market, special precautionary matters and so on.
If you are interested in one or several services in the following topics, please contact us directly, so we can assess your situation and needs in detail.
Apart from consultancy services, we offer several work solutions that can be purchased and tailored to your company’s specific circumstances and project needs.
Consultancy in GMP and compliance topics for cell line development at TAL – The Antibody Lab, an Austria-based start-up company.
Consultancy in GMP and compliance topics for vaccine development at AngoThera, an Austria-based start-up company.
Consultancy in GMP compliance for a tissue graft project at AME – Applied Medical Engineering, part of RWTH Aachen University, Germany.
- Development strategy for biosimilars with a focus on technical as well as quality profile aspects at a Belgium-based start-up company.
- Technology transfer expertise for all API and DP aspects of a Phase II/III product at a China-based start-up company.
- Consultancy in CMC development for an oncological investigational new drug at a German University.
- Tech transfer and scale-up design for biosimilar projects at an Iceland-based production facility.
- Advisor in technology transfer projects at a Switzerland-based CMO.
- Media development and CMC technical consultancy at a USA-based biotech company.
- Development of a Business Plan for entering the Biosimilar market (from DNA to market product, from investments to operating costs of a production facility) at an undisclosed pharmaceutical company.