In this episode we decided to use a new approach in regulatory affairs and tell people how to fail their BLA (Biologics License Application) and piss off their FDA reviewers at the same time. In order to do that, Arvilla Trag, who is a Chemistry, Manufacturing and Controls (CMC) industry expert helped by walking us through the FDA CMC Hell where we met all kind of people from pharma companies and heard all kind of interesting ideas on how not to complete the CMC section.

We would like to apologize to anyone who accidently learnt something from our entertaining discussion!

You can read the transcript of our discussion here: https://solutionsop.co.uk/2026/04/17/visiting-the-9-circles-of-fda-cmc-hell-with-arvilla-trag/

In this episode we are discussing the clinical research opportunities in Japan. Our guest is Tetsu Yung who is a consultant with extensive experience in pharma and CRO industry in Japan. We cover the main requirements for setting up clinical trials in Japan and the timelines for obtaining approvals. We also talk about initiatives from the Japanese government to encourage pharma start-ups to set up in Japan and conduct their clinical research in the country.

You can find the script for the interview here: https://solutionsop.co.uk/2026/04/10/clinical-research-opportunities-in-japan-interview-with-tetsu-yung/

In this episode we are talking with our Senior Clinical Data Quality Manager, Lydia Ainsworth, about animal testing in clinical research.

Join us to learn:

• What are the most common animals used in animal testing,
• The typical cost for using animals in clinical research,
• The ethical issues around using animals,
• When animal testing is needed in drug development
• What are the alternatives of animal testing.