Regulatory Affairs
Combining our detail-oriented approach, close monitoring of site timelines, and up-to-date training on FDA and HIPAA requirements, CTMS is an ideal partner to assist you with Regulatory Affairs. Our goal is a seamless appearance to the FDA submissions previously submitted by sponsor companies. We can assist with the following aspects of Regulatory Affairs:
Complete regulatory document collection and review in clinical trials with either a drug or biologic product
Authorization of drug shipment to investigators
FDA submission of IND Protocol Amendments: a new protocol, change in protocol, and/or new investigators
FDA submission of IND Safety Reports and/or 15-Day Alert Reports

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