CMC explained: the questions to ask early
An introduction to the chemistry, manufacturing and controls considerations that can influence product development.
Discuss CMC planning →Resources
Knowledge to help you move forward.
A growing library of practical topics for founders, biotech teams and pharmaceutical leaders navigating product development.
Topics for life-science innovators
These are proposed resource themes for the website. They can become full articles or downloadable guides as content is approved.
From university research to a biotech startup
A framework for thinking about evidence, development milestones, expertise and partner needs.
Talk through your idea →Preparing for scale-up and technology transfer
Key areas to consider when moving from development work toward repeatable manufacturing.
Discuss manufacturing readiness →Planning for regulatory milestones
Why documentation, evidence and regulatory questions should be considered as part of development planning.
Discuss regulatory planning →Identifying the next critical decision
A way to organise uncertainties, dependencies and near-term actions across a development programme.
Talk about your programme →Connecting technical plans with commercial goals
How product-development decisions relate to resources, timing, partners and longer-term objectives.
Discuss your strategy →Have a question that isn't covered here?
Tell us what you are trying to solve.