Single Bio for EU and US [Regulatives / Guidelines]

posted by bharathi – India, 2011-11-14 07:50 (5337 d 15:00 ago) – Posting: # 7662
Views: 3,577
(edited on 2011-11-15 05:12)

Dear All,

Please can anyone here help me out to answer-

We are planning to launch our product in both US and EU countries. Innovator for both US and EU is the same (even manufacturing site being the same).
Can we perform Bio with any one of the Product (US/EU), and confirm that it holds good for the both.

Thanks in advance

Complete thread:

UA Flag
Activity
 Admin contact
23,655 posts in 4,993 threads, 1,571 registered users;
225 visitors (0 registered, 225 guests [including 111 identified bots]).
Forum time: 23:50 CEST (Europe/Vienna)

The great tragedy of Science – the slaying
of a beautiful hypothesis by an ugly fact.    Thomas Henry Huxley

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5