Registration Affairs
Noahpharm can provide professional registration services for chemical drugs, biological products and medical devices, assist drug development and shorten the time to market. During product registration, the rich practical experiences enable Noahpharm to precisely grasp product registration essentials. Noahpharm is deeply familiar with the medical product development process and technical requirements, and keeps sound communication with regulatory authorities. Noahpharm maintains efficient two-way communication with customers and regulatory authorities in terms of procedures, regulations and technical compliance to ensure rapid project advancement.
• Various kinds of applications such as clinical approval application, international multi-center clinical trial application
• Sino-US/Sino-Europe application
• Meeting of communication with CDE and expert review meeting
• Drug registration counseling, strategic planning recommendation and risk assessment
• Quality control and management of registration dossier
• Counseling