Chemistry Manufacturing and Control
Chemistry, Manufacturing and Control often abbreviated to CMC, represents a detailed overview of investigational data on your Drug Substance and Drug Product. This includes the origin of your starting materials, the packaging of both DS and DP and the analytical methods required to (release) test both Drug Substance and Drug Product. The CMC data should reflect your ability to produce, analyze and store a packed Drug Product with sufficient quality and stability for administration to healthy volunteers or patients. The CMC of both your Drug Substance and Drug Product will be described in detail in the IMPD (Investigational Medicinal Product Dossier) that will be part of the submission data package that is reviewed by the authorities for approval of your clinical study application.
Chemistry, Manufacturing and Control of the Drug Substance
Once you made the decision to move your lead compound to the preclinical stage, sufficient amounts of material need to be produced and accompanying analytical quality testing methods needs to be developed, installed and validated. Saudade Pharma has ample experience in chemical synthesis, development and scale-up of your lead compound as well as strong analytical background to support you with setting-up a robust GMP manufacturing process with accurate and relevant analytical methods.
Once the process for the manufacturing of your Drug Substance is ready, material manufactured via this process will be stored to show the required stability. Saudade Pharma can help you create a lean and mean stability (testing) program that will result in the best possible storage conditions with the least amount of testing.
Chemistry, Manufacturing and Control of the Drug Product
Formulation development is an important part of you product as it can determine the distribution of your compound in the human body. It can also turn your bad tasting or poorly dissolvable Drug Substance into a sweet candy or concentrated solution for injection. Once your formulation shows enough stability under required storage conditions i.e.. to cover the time between manufacturing and actual administration to the patient, the manufacturing process can be scale-up to the required batch size. Analytical methods based on both your Drug Product and the Ph. Eur. mandatory tests will be developed, tested and validated to release test your Drug Product.
Once the process for the manufacturing of your Drug Product is available, material manufactured via this process will be stored to show the required stability. Saudade Pharma can help you create a lean and mean stability (testing) program that will result in the best possible storage conditions with the least amount of testing.