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We offer accurate information, advice, guidance, and services from professionals who have worked for major drug development companies in addition to the FDA and have specialized knowledge of the regulatory processes of the FDA.
If you are an academic (didactic professor, clinical professor or healthcare professional) we are here to help. The regulations involving the FDA can be overwhelming to even the most seasoned professional who aren’t familiar with regulator affairs and CFR 21-22. We support professors having a better understanding of what the FDA does and therefore do not charge to answer basic guidance questions regarding the FDA, regulatory questions, emergency use, compassionate use questions, or basic policy and procedures regarding investigational medicine and drug safety. Contact us with your university email and title.