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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 on 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. We do not charge to answer basic guidance questions regarding the FDA, regulatory questions, compassionate use questions, or basic policy and procedures regarding investigational medicine and drug safety.