Our Advantage:

Offering professional and high-efficiency regulatory affairs registration and consulting services.

Services:

• Help to successfully prepare and submit application documents, and conduct follow-up maintenance, such as the amendment of questions raised in the application documents, revision/annual report, renewal, and etc.

• Support electronic submission, prepare DMF / ASMF / CEP /ANDA application documents in format of eCTD.

• Transfer the registration documents to eCTD format.

• Global registration strategy and market analysis.

• Investigational Medicinal Product Dossier (IMPD).

• Pharmacovigilance.

• BE information.