Replies to post #226589 on Elite Pharmaceuticals Inc (ELTP)

[PH4RM4C3UT1C4LS]

SOPs aren't too hard to create. I've written and edited/reviewed quite a few SOPs for BP. Hardest part is getting everyone within the company's team to agree on the wording. Seeing as Eltp is a relatively small company, the head honchos in charge have a ton of experience, Nasrat is a lawyer, and we have a former FDA member guiding us, I'd say it's pretty easy for them to write a procedure to monitor ADE/ADRs.

-DoctaPharma

[dr_lowenstein]

It failed once already. Let's hope that it does not ultimately end up in the scrap heap of the 16 % of NDAs that never get approved.