Drug Registration & GXP Auditing

 • Prepare DMF / ASMF / CEP/ANDA dossiers in format of eCTD or Nees according to client’s requirement

• Global registration strategy and market analysis

• Support electronic submission

• Prepare product registration dossiers

• Transfer the format of registration document to eCTD

• RA dossier Maintenance

• Clinical research drug document (IMPD)

• Pharmacovigilance

• BE management