Key factors to assure the successful development and approval of biosimilar products include careful strategic planning, understanding the regulatory landscape and smart maneuvering around the maze of guidelines. In addition, optimal study design, interaction with regulatory agencies, project management for optimal timelines and understanding the operational challenges are crucial to ensure timely delivery and minimize cost Regulatory Strategic Planning Clinical Development Plans Due Diligence Regulatory Agency Interaction including preparing briefing packages in collaboration with client, organizing Agency meetings and attending meetings Global Reach Project Management Gap Analysis for expanding portfolio into other territories Risk Management Plans