RTI can assist with product development plans, develop timelines, preparation of regulatory submissions, including protocols, reports and production outlines. RTI will work with regulatory agencies to make sure your product moves through the licensing process in a timely manner.
RTI will work with clients to develop detailed and realistic licensing/development plans.
Advantages of developing the plan:
A variety of submissions to CVB will be required throughout the life of the project.
RTI staff has had extensive experience in study design and protocol development. This includes:
RTI can provide study reports that are "submission ready" to be sent to CVB as well as European regulatory authorities.
In addition, RTI provides services for manuscript preparation for submission to scientific journals.
RTI staff has extensive expertise in communications between firms and the regulatory agency. Communications involve written (electronic and hard copy), conference calls and face to face meetings. RTI retains a good reputation as well as a good support rapport with the CVB staff.