Our work

Case Studies

We push the boundaries

Featured Projects

Biopharmaceuticals

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...

Read Case Study
Biopharmaceuticals

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...

Read Case Study
Biopharmaceuticals

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...

Read Case Study
Coming Soon
Biopharmaceuticals

Developing and implementing quality systems to enable clients to be GMP certified

Coming Soon
Coming Soon
Biopharmaceuticals

Review of medical device technical files and transition from MDD to MDR

Coming Soon
Coming Soon
Biopharmaceuticals

Approved Dossier compliance and conformance review to address registration drift and avoid regulatory action

Coming Soon
Let's discuss your project

Get in touch today

Talk to us