New Drug Application (NDA) is the process by which a pharma company approaches the regulatory body to sell and market a new drug.

There is a significant amount of  documentation which the pharma company needs to submit in an NDA. The following are the important aspects which should be part of NDA:

• Detailed test of clinical trials conducted
• Ingredients and composition of the drug
• Any side-effects noticed during animal studies, and whether the risks outweigh the benefits of the drug
• Manufacturing, processing, and packaging processes
  

New drug manufacturing requires huge amount of research in their laboratories. There is a lot of to and fro before the exact formulation is reached. This process may require involvement of experts and KOLs. Thereafter, extensive tests are carried out on animals to discover side effects. Once this stage is cleared, the drug is tested on humans to test safety and effectiveness.