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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

    QA:

    · Contract manufacturer audit

    · Contract laboratory audit

    · Supplier audit

    · FDA audit support

    · Consulting

    · Simulation of the audit

    · Approve for the validation

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