Dear Forum members,
How to plan for EU submission, if the generic product development
project was executed by considering only US market for a parenteral
product.
Some concerns are related to
1. Reference product
2. Number of batches executed
(Exhibit & proposed commercial)
3. DS, Excipient, inprocess & finished
product specifications.
3. Stability studies
Regards
RAJANEESH.BR
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Rajaneesh.br
brrajaneesh@gmail.com
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