INO Therapeutics Selects Octagon to Provide a Foundation for Their eCTD Capability Strategy
Summary
Richard Bourne, vice president of Regulatory Affairs at INO Therapeutics, LLC., noted, “We are developing a strong foundation for becoming eCTD-ready.The solutions we chose complement our current capabilities and provide practical guidance on eCTD throughout the submission process.” In recent months, the U.S. Food and Drug Administration has announced a change to a proposed rule and conducted a Part 15 Public Meeting on the topic of electronic submissions, eCTD and electronic data.“We chose Octagon’s solutions because they understand the business requirements surrounding submission development and their solutions clearly demonstrate that practical knowledge.” Jim Walker, chairman and CEO added, “As we follow the recent agency activities around electronic submissions and electronic data, we see that implementing eCTD is becoming a priority for many competitive organizations in our industry.Finally, ViewPoint eCTD Complete is a technology solution that pairs Octagon’s innovative technologies with expert support services to provide core submission capabilities including compilation, issue management, viewing and validation.Richard Bourne, vice president of Regulatory Affairs at INO Therapeutics, LLC., noted, “We are developing a strong foundation for becoming eCTD-ready.“We chose Octagon’s solutions because they understand the business requirements surrounding submission development and their solutions clearly demonstrate that practical knowledge.”Jim Walker, chairman and CEO added, “As we follow the recent agency activities around electronic submissions and electronic data, we see that implementing eCTD is becoming a priority for many competitive organizations in our industry.