cCDMO

Our RA team focuses on providing CMC services and preparation of registration and filing of the M2 and M3 modules of CTD data and maintenance of API DMF documents for domestic and overseas clients from Investigational New Drug application (IND) to various stages of clinical trials to New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) etc.

How does it work?

Our PRD, ARD, tech-transfer, and scale-up manufacturing teams work closely to collect the raw data for each phase of the CMC study, and then RA team will prepare registration and filing according to the project stages that in line with the regulatory requirements of each region.

Raw data and information collection during project execution.
Regulatory compliance is in consideration at all stages of the project.
Preparation of the registration and filing according to the overall project timeline.
The project team(PRD, ARD, tech-transfer, manufacturing) complete their part of information respectively
The RA team is responsible for compiling regulatory compliant registration documents
Timely, fast, and transparent communication with customers

Why Bellen?

Our RA team has a deep understanding of regulatory requirements, we provide comprehensive product life cycle service management for every stage of clinical studies. We can quickly organize and prepare CTD documents and API DMF according to regional regulatory requirements.