Since 2003, eCTD has been accepted by several Health Authorities around the world. Its standard has evolved incrementally over time. Based on the Health Level Seven (HL7) standard called RPS (Regulated Product Submission), eCTD 4.0 brings in major changes and introduces certain substantial updates. The updates focus on addressing a few key constraints that both Agencies and sponsors have discovered over the last two (02) decades.

eCTD submissions are one of the key steps in the development of pharmaceuticals. What if you miss your product launch due to a delay in eCTD submissions? The cost of lost opportunity per day delay in the product launch is expected to be in the millions. Subsequently, the cost of non-compliance to the Health Authority (HA) timelines and regulations is huge. With the fast-approaching submission deadlines for multiple products in their portfolio, life science companies often struggle to efficiently plan, execute, and track their submission activities.