We push the boundaries
Guiding our client to develop and successfully register a third-generation vaccine
Our EU client — an established manufacturer of vaccines that are supplied globally — developed a vaccine against Hepatitis B that they had demonstrated...
Strategic use of a comparability protocol to bridge an intercontinental technology transfer using bio / analytical data and avoid bridging clinical studies
Woodley BioReg was involved in drafting the regulations for Well-Characterised (now Well-Specified) Biologics and Comparability Protocols which have now been in effect for over...
Successful scientific advice to accelerate the development and registration of a biological product / biosimilar
Our client was based in the EU and was seeking to develop a biosimilar to an existing product approved in the US. As a...