In the fast-changing China environment, Regulatory Landscape knowledge and experience are critical factors of success. At Proswell we help you to develop exclusive strategy for your product to achieve regulatory compliance and to make sure the study will start as quick as possible.

• Regulatory Strategy Development

• Health Authority Communication

• Health Authority Liaison

• Regulatory Consulting

• IND Filling & Maintenance

• NDA/BLA Filling & Maintenance

• Global Synchronization and MRCT Support

• GAP Analysis

• Dossier Development and Review

• Overseas Market Authorization Obtaining

• Certified Translations in Various Languages

• Clinical Trial Registration