Regulatory Interview for CMC (Chemistry, Manufacturing and Controls)

[Wendy01]

Does anyone have experience in being interviewed for pharmaceutical regulatory (CMC) ? What should one focus on and type of questions to be expected from the interviewer?

Thanks in advance

[Jim Wynne]

Originally Posted by Wendy01

Does anyone have experience in being interviewed for pharmaceutical regulatory (CMC) ? What should one focus on and type of questions to be expected from the interviewer?

Thanks in advance

Do you have training and/or experience in this area? What's CMC?

[Ajit Basrur]

Originally Posted by Jim Wynne

Do you have training and/or experience in this area? What's CMC?

CMC stands for Chemistry, Manufacturing and Controls for demonstrating to the FDA the ability to consistently manufacture, store and control drug product. This information constitues about one thirds during the New Drug Application (NDA)

[Ajit Basrur]

Originally Posted by Wendy01

Does anyone have experience in being interviewed for pharmaceutical regulatory (CMC) ? What should one focus on and type of questions to be expected from the interviewer?

Thanks in advance

Hi Wendy,

There is lot of information on FDA for CMC. You could also have a look HERE

All the best to you

[Wendy01]

Thanks for the site, it is very helpful source of information.