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        Quality & Pharmaceutical Management

        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.

        Drug registration:

        · 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

        · Consulting

        · Simulation of the audit

        · Approve for the validation


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