A clear regulatory strategy: Maximizing development productivity by keeping the end in mind

Every drug or product development journey should begin with the end goals in mind. Early development of a regulatory strategy, as it relates to critical planning data/documents, allows drug sponsors to streamline clinical trials and prepare for regulatory submissions, ensuring optimal outcomes. Two specific planning documents—the Target Product Profile (TPP) and Comprehensive or Clinical Development Plan (CDP)—provide critical blueprints that help inform these efforts.