Regulatory Affairs
Our Advantage:
Offering professional and high-efficiency regulatory affairs registration and consulting services.
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.
