Our quality and regulatory team has years of experience on GMP audit, US FDA Submission Management & regulatory strategy evaluation, to ensure our customer achieve regulatory compliance first time, and all the time.
· Apply for US ANDA
· US IND/NDA submission support
· Prepare and submit US EDMF and its amendment.
· US DMF deficiency response support.
· Apply for CEP
· Format conversion for eCTD
· Establishment registration, GDUFA self-Identification and NDC/NHRIC labeler code request in US FDA
· Drug registration strategy support
· Improve the feasibility evaluation for import/homemade pharmaceuticals registration
· Prepare and submit for import/homemade pharmaceuticals registration (include translate).
· Registration for quality consistency evaluation of generic drugs
· Contract manufacturer audit
· Contract laboratory audit
· Supplier audit
· FDA audit support
· Simulation of the audit
· Approve for the validation