Abstract: At the research institutes and the university research facilities, researchers are well experienced and knowledgeable for synthesizing a molecule, determining its activities, toxicity etc. They find its therapeutic value and also know the importance of their research work. But as a basic researcher, we have hard time to put the plans to bring this valuable molecule to reach up to the mankind. We have several options to proceed; to get an IP, sell it to pharmaceutical company, or find investors and set up a lab to get file an application to FDA to get approval for Investigational New Drug (IND) and then file for New Drug Application, (NDA).
In this presentation, we will discuss the processes that are required by FDA for filling an IND. We will present R/S Tech-Prob solutions, LLC capabilities and experiences that we provide to researchers to prepare a Chemistry and manufacturing control, (CMC), section for filing application to get an IND from FDA.
October 21, 2016
Videoconference: Jupiter Campus – SR 270
Helping Hands for
Pharmaceutical Products Development
I Discovered a Molecule: Now What to Do??
By: Rekha Shah