Chemistry, Manufacturing and Controls
Regulatory agencies must have a degree of confidence in the level of information surrounding the CMC even at the earliest development stages.
Process understanding is the foundation of good manufacturing practice. Omni-EDS helps clients know which steps and variables in the manufacturing process need to be controlled and why.
In a product's earliest stages, it is important to understand the development of the actual product and communicate that in the CMC section of Investigational New Drug applications (INDs) and New Drug Applications (NDAs). Decisions made on how to formulate early on can have significant immediate and long-term effects, both positive and negative, on the CMC plan and, ultimately, on the product development path. In fact during the pre-clinical stage formulation experts must determine how to make large enough quantities of the drug to use in clinical trials. It is common for techniques used to make a drug on a small scale in the preclinical stage may not translate easily to larger production. Omni-EDS experts help clients by conducting formulations assessment and create development plans to navigate critical CMC decisions and empower the drug development plan.
The goal of Quality Systems is to consistently produce the same or similar product to that demonstrated to be safe and effective in studies. Omni-EDS experts help build and maintain the connection in quality between the drug used in clinical trials and the marketed drug.