Bioequivalence and Bioavailability Forum • BE NOC Regulatory Check list for

rsr
☆

India,
2014-11-03 07:07
(3460 d 19:56 ago)

Posting: # 13821
Views: 2,566

BE NOC Regulatory Check list for [Regulatives / Guidelines]

Dear All,

I would be grateful if any one could provide me with some feedback regarding " BE NOC CHECK LIST".

Please let me know that, is thier any guidence/Checklist for obtaining of the BE NOC for " conducting study in india with an inidan reference product"i.e.Both Test and reference product from india, product launch in india.

The guidlenes are provided checklist for "BE NOC FOR EXPORT PURPOSE".sO, I want to conduct study as mentioned above,what is the checklist/requirments.

regards,
RSREDDY

priya ☆ India, 2014-11-03 10:44 (3460 d 16:20 ago) @ rsr Posting: # 13823 Views: 2,132	BE NOC Regulatory Check list for Post reply
	Hi RsReddy, ❝ The guidlenes are provided checklist for "BE NOC FOR EXPORT PURPOSE".sO, I want to conduct study as mentioned above,what is the checklist/requirments. You should follow the same BENOC checklist issued by CDSCO for the BE studies meant for Indian submission also. Priya.

rsr ☆ India, 2014-11-03 10:47 (3460 d 16:17 ago) @ priya Posting: # 13824 Views: 2,085	BE NOC Regulatory Check list for Post reply
	thank you Ms.Priya