Our cGMP Clinical Manufacturing Process

The process begins with a thorough evaluation of method requirements for a successful transfer of your existing process into our modern laboratories, where we evaluate and enhance it to meet cGMP standards. This process includes developing precise analytical methods, such as synthesizing known impurity markers, and conducting comprehensive ICH stability evaluations to ensure the highest product quality and consistency.

Once we have refined the cGMP process, we transfer it to our cutting-edge manufacturing plant for large-scale cGMP production. This thorough approach establishes a robust foundation for a seamless transition to the commercial stage of your project. As you prepare for the NDA (New Drug Application) submission, Agno Pharma is here to support you with our extensive experience in regulatory submissions into all major geographical markets. We assist clients of all levels, from seasoned professionals to first-time innovators, ensuring that the CMC section of your application is meticulously prepared for a successful and defensible submission.