Registration Service

Assist in registering imported active pharmaceutical ingredients in China and provide high-quality company registration services:

Registration agency service: Provide registration agency services for imported raw materials.

Outline of application materials: Provide application materials and prepare an outline.

Gap analysis and risk estimation: Conduct gap analysis on the registration data, estimate risks, propose corrective measures, and ensure that the registered active pharmaceutical ingredients pass the technical review smoothly.

Review, translate, and improve registration materials: Conduct review, translation, improvement, writing, and submission of registration materials.

Registration inspection application and tracking: registration inspection application, sample delivery, tracking, and problem resolution.

Full process tracking and problem solving: Track the entire process of raw material registration, submit supplementary problem solving and supplementary response materials.

Registration information update and technology transfer: API registration information update, including major changes, moderate changes, minor changes, and basic information changes;Transfer of registration data and technology for active pharmaceutical ingredients.

Submission of annual report materials: Submission of annual report materials for registered active pharmaceutical ingredients.

DMF file filing and associated review: DMF files are filed and associated reviewed in CDE to support the approval of drug formulations.