Pharmaceutical Excipient IPEL china NMPA register Cost & time

◄ Pharmaceutical Excipient IPEL china NMPA register Cost & time ►

Tags: | NMPA | Pharmaceuticals | Drug | 药监局 | 医药品 | 药品 |

Generic Pharmaceutical Excipient IPEL china CFDA registration Cost:

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

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