CMC (Chemistry, Manufacturing and Controls) is one of the most important activities in drug product development. It occurs during all stages of the drug development cycle and ensures quality and consistency during the manufacturing of the pharmaceutical product. CMC is a critical component of all pharmaceutical products that cannot be overlooked. To get approval of a new biopharmaceutical drug also the chemistry, manufacturing and control (CMC) module (Module 3 – The Quality section of the CTD) is of vital importance.
What should you consider at what stage during drug development? How to prevent delays and costs in regulatory approval as a result of incomplete CMC sections? When to start as a young company with the CMC dossier and how to collaborate with CMC experts? Experts from consultancy and biotech companies will share their insights and experiences.