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Pharmaceutical Excipient IPEL china CFDA register Cost & time
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Generic
Pharmaceutical Excipient IPEL china CFDA registration Cost:
ITEM |
COST |
TIME |
NOTE |
China CFDA Registration consulting & Legal responsibility
Agency |
Contact us |
1 Months |
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Technical documents Translation |
Contact us |
0.5-1 Months |
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CFDA Application Dossier Draft, Pre-review, Submit |
Contact us |
3-5 Months |
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NICPBP
Excipient
Tests & Follow up |
Contact us |
3-6 Months |
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Bioequivalence
/Pharmacokinetics
Study
& CRO Service Cost |
Contact us |
3-6 Months |
?? |
CDE Technical Evaluation & Follow up |
Contact us |
6-9 Months |
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CFDA IPEL Approval & Follow up |
Contact us |
3-6 Months |
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Other
(Document Notarization etc.) |
Contact us |
0.5-1 Months |
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Total: |
Contact us |
18-24
Months |
Not include the BE cost |
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