Regulatory Strategy for Drug Development, Progam Management and Leadership
Evaluate, develop, and monitor regulatory strategy for drug development
Prepare and manage product development plans, to include identification of critical tasks, preparation and maintenance of project timelines, oversight and technical expert coordination
Project reporting to team members, senior management, and Board of Directors
Conduct due diligence assessments for acquisitions and other investment decision-making to ensure that regulatory strategy for drug development meets FDA requirements
Provide advice on Orphan Drugs Designation, Fast Track, Breakthrough Therapy, Accelerated Approval, ANDA and 505(b)(2) submissions as they relate to biological products
FDA regulatory affairs services for regulatory options and development pathways
