Regulatory Affairs

JANIX’s resources, know how, and first-hand experience will strengthen chances of success and streamline the process of coordinating with regulatory authorities. 

Our clinical trial approval and registration capabilities extend worldwide, with the ability to support Phase I safety and feasibility to large multinational pivotal Phase III studies, as well as Registration Studies.

Direct participation with regulatory agencies in the US and international settings, including Europe, Africa, Israel, and Asia Pacific allow for a strong platform to assist in the preparation and  submission of regulatory documents. JANIX can help coordinate the entire process, offering a vertically integrated approach to gain approvals.

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