Medical equipment registration declaration:

Medical equipment registration declaration service refers to the service provided by professional institutions or individuals to help pharmaceutical and medical device manufacturers complete relevant registration and declaration procedures, prepare necessary materials and communicate and coordinate with regulatory agencies on their behalf.

• Formulation and guidance of registration strategy

• Pre-review and feasibility assessment

• Preparation and declaration of new drug application (NDA) documents

• Investigational new drug (IND) of Sino-US double reporting

• CDE communicating application and guidance

• Editing, review and submission of the application materials

• Solve difficult questions in review/approval

• Management and tracking of the whole registration process

• Assist in on-site verification and inspection