cCDMO

Enhance the robustness of your process with a regulatory starting material(RSM) study strategy and process quality risk assessment(QRA) strategy tailored to the needs of your project, leading to the successful completion of at least three consecutive process validation batches to enable and accelerate your new drug launch process.

With a professional later phase project team focusing on the study of regulatory starting materials(RSMs) and process quality risk assessment(QRA) to improve the robustness of the process, so that your project can pass the process validation process smoothly and take a key step towards the NDA application.

How does it work?

Our later-phase project team will communicate with your technical and registration team to determine the regulatory starting materials(RSMs). Then, we will run a quality study based on a set of processes and strategies for the regulatory starting materials(RSMs). Our service and strength areas include but not limited to:

Raw material vendor qualification for RSMs
Historical data collection of typical batches
Identification of impurities
Impurities synthesis and reference standard characterization
Impurity fate and spiking studies
Analytical method confirmation for RSMs
Release specification setting for RSMs
RSM study report

In the meantime, the process quality study and control for each step after regulatory starting materials(RSMs) to the APIs will be thoroughly evaluated in accordance with a set of systematic and complete processes and strategies. Our service and strength areas include but not limited to:

First version process failure mode and effects analysis (FMEA)
Design of experiments(DoE)
Experiments execution
Second version process FMEA
Definition of critical process parameters(CPP) for NOR and PAR
Analytical method confirmation for intermediates
Release specification setting for intermediate
Conformation of final process
Quality risk assessment(QRA) study report

The final version of the process will be transferred to plant after PRD team completes RSM study and the quality risk assessment(QRA) study. PRD team will work closely with plant process engineers to fully review and prepare the technical documents related to the process validation. We will ensure timely communication with your team to reach agreement before execution of the process validation batches under the cGMP conditions, followed by a complete validation report for the purpose of your NDA filing.

Why Bellen is your preferred partner?

We have valid manufacturing licenses
We have a professional later-phase project execution team
We have a professional later-phase project management team
We have rich practical experiences in later-phase project R&D and manufacturing
We have established a robust quality system to guide later-phase project R&D and manufacturing
Tech-transfer is carried out seamlessly between process R&D team and plant process engineers
We promote transparent and effective communication