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:
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Complete regulatory document collection and review in clinical trials with either a drug or biologic product |
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Authorization of drug shipment to investigators |
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FDA submission of IND Protocol Amendments: a new protocol, change in protocol, and/or new investigators |
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FDA submission of IND Safety Reports and/or 15-Day Alert Reports |
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