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IND Preparation and Submission

The Investigational New Drug (IND) application process is long and complicated. SRI can help you troubleshoot potential problems prior to the submission of your IND to the FDA. SRI can assist in preparing you and the documentation for a pre-IND meeting with the FDA. We will also prepare the actual IND for your organization. Once the IND is in place, SRI will work with you and other contractors to keep all IND information current and in compliance with FDA regulations. SRI will assume responsibility for preparing all sections of the IND application and Master Files as needed. Once the IND has been filed, SRI will work with other contractors to track changes to keep the information current for submission of amendments and for the FDA Annual Report. SRI can receive, coordinate and assemble documents for supplemental submissions to the appropriate Master File and/or IND. SRI can also set up a system to communicate with and receive documents from various subcontractors and holders of the Master files and INDs.

SRI's Regulatory Affairs Department can:

• Assist in preparing your organization for a pre-IND meeting with FDA
• Prepare, assemble and index an original IND for FDA submission
• Coordinate and assemble the manufacturing, preclinical and clinical documents for review and prepare an IND application
• Prepare and update Master Files
• Prepare and update Investigator's brochure
• Prepare Annual Reports
• Provide additional submissions and amendments as necessary for successful filling and maintenance of an IND

SRI has extensive experience with IND preparation and a longstanding relationship with the FDA. We can use these assets to move your drug through the IND process and into the clinic.

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     Last Updated Mar 19, 2009