QbD for Biotech
Our QbD Platform
Tailored integration of QbD to meet your company needs. We create a QbD platform to support your development efforts which is fit for purpose with respect to your company size and structure and in line with ICH expectations.
Supported QbD elements
Defining (Quality) Target Product Profile (Q)TPP
Defining critical quality attributes (CQAs)
Process risk assessment
Drug product risk assessment
Process design and control strategy
DoE and Statistical data analysis