GMP Stability Studies

At MOD3 Pharma, we manage the stability testing process for pharma partners, ensuring they are equipped with rich data on the shelf life and storage conditions relevant to their drug product.

We have the chambers you need on-site, and we have the methods you need from the release specification. Your drug is under our constant supervision. We develop stability protocols for your drug that will satisfy the FDA and EMA to allow your clinical trials to move forward, and to provide you with the data to ensure the stability of your product. We are passionate about the precision of our analytical methods because we know how important that is when trying to predict the long-term stability of your product from a few short-term timepoints.

We provide you with updated stability tables after each pull, which you can use to justify continued dosing in the clinic or in satisfying your management that the commercial product meets the stability requirements you have built into your models.