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Registersubmission to two countries [Regulatives / Guidelines]
Hello PSS,
Plain and simply: Yes.
❝ Can a Bioequivalence study planned as a three way cross over study i.e. one test and two refrence formulations be submitted to two different countries (...) can this study be submitted to both UK MHRA and USFDA since this study is conducted based on the guidences of both the countries and reference IPs have been procured from both the countries?
Plain and simply: Yes.
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Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- submission to two countries sarada06884 2013-07-06 11:10
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- submission to two countriesElMaestro 2013-07-06 11:54
- submission to two countries drgunasakaran1 2013-07-07 08:03
Ing. Helmut Schütz