Drug registration support services

Services purpose:

Provide registration service of target market as required by customer and ensure that products of customer meet drug registration requirements of target market’s authorities before entering target market of products.


Services contents:

  Services scope

Drug registration support services include registration of European and American CEP/ASMF/DMF/WHO PQ and Chinese drug registration.

  Services flow chart

  Verification of prerequisite before registration

  Check whether existing equipment, facilities, premises and quality system are complying with GMP requirements of target market.

  Provide written inspection report and improvement suggestions and discuss the improvement plan together with customer.

  Registration services plan

  Prepare registration services plan according to improvement plan and registration flow chart of target market.

  Registration implementation

  Guide customer to do the impurity study, quality study, structure study, stability study and other necessary study.

  Collect and review study data provided by customer.

  Prepare registration dossier with CTD format.

  Verify together with customer the accuracy and authenticity of information in the registration dossier.

  Finalization, printing, signature, scan, eCTD formatted, CESP or ESG submission of registration dossier.

  If necessary, guide to receive registration inspection, supply registration studies and registration data.

  Obtain registration permission.