taiheng-凯发平台

· 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