BioOutsource — cGMP compliant biotesting
Company Overview
Our aim is to become the leading partnering cGMP organisation for the outsourcing of vaccine and biologic product release world wide.
The rapidly changing requirements for the regulatory release of vaccine and biologic products already cause difficulties for both small and large organisations. This can cause delays to product development due to the lack of internal resources within many organisations. BioOutsource scientists have many years of experience and can reduce the time spent on the development process and provide a reliable resource for product release testing to specification within a cGMP environment. BioOutsource can also reduce the requirement to maintain a cGMP quality control facility within an organisation reducing the overall costs dramatically.
BioOutsource provides a range of validated assays as well as technical and regulatory consultancy services. Our team of scientists have considerable experience in the development, optimisation and validation of assays required for batch release. All of our testing is performed in a custom built facility dedicated to cGMP compliance. We only offer our batch release testing to cGMP compliance and will be supervised by the Medicines and Healthcare products Regulatory Agency. This will fulfil both the EMEA and FDA requirements for product release in Europe and the United States.
