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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