What Are The Stages of Drug Development?

For any drug to get FDA approval, it must pass through several stages of development and manufacturing to ensure the product is safe, efficacious, and has passed regulatory requirements. 

SovPharm is the only CDMO pharmaceutical company that you need. We aid you through the stages of developing a drug. Our staff and facilities can help you determine what tests you need to conduct and perform all the necessary tests and studies needed to get FDA approval. 

We thought it would be a great idea to show our clients an in-depth overview of the stages in drug development and the necessary studies we conduct. Keep in mind that this is only a guide, and it has been simplified significantly. If you have any specific questions, contact Sovereign Pharmaceuticals at () to speak to a knowledgeable resource. 

Stages In Drug Development

Discovery

Discovery begins with choosing a biochemical mechanism involved in a disease condition. Scientists identify candidates from academic and pharmaceutical/biotech research labs and are tested for their interaction with the drug target. 

Every one of the 5,000 to 10,000 molecules for each drug goes through a rigorous screening process which can include genomics, proteomics, and other screening methods. Once scientists confirm interaction with the drug target, it is time to choose one or more lead compounds for the drug. 

Product Characterization

When the molecule has therapeutic traits, it must be characterized. Its molecule size, shape, strength, weaknesses, preferred storage conditions, toxicity, bioavailability, and bioactive must be carefully defined. 

Early-stage pharmacology studies help characterize most of the foundational mechanisms of action of the formula. 

Formulation, Delivery, Packaging, Development

CDMOs must develop a unique formula that ensures proper drug delivery parameters. Drug formulation and delivery may be modified continuously as the drug passes through different stages in development, even after final approval. 

We also perform extractable and leachable studies on containers and packaging to guarantee the drug's stability. Our scientists look at all the parameters involved with storage and shipment, such as light, temperature, time, humidity, etc. it is important that we find a way to transport the final product to distributors, so they arrive potent and sterile. 

For all your solid dose cdmo and liquid manufacturing cdmo needs, contact us today.