The Common Technical Document can sometimes be a bit daunting. As a fundamental part of the approval process for your product, whether you are a huge multinational corporation or a small biotech company, it is essential to know how to use the CTD.
As more cell and gene therapies move towards commercialization, it is important to know how to adapt the CTD for your advanced therapy.
In the below guide, Chris Bravery, Consulting Regulatory Scientist of Advanced Biologicals, provides real-world examples of how to interpret and successfully complete the CTD, with particular focus on the following four techniques...
- Applying the CTD to advanced therapies
- Understanding section names
- Batch analysis
- Refining your writing style