eCTD v4.0

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.

Regulatory submissions and publishing tasks have traditionally been laborious involving hours of manual efforts for formatting documents, generating agency-compliant PDFs, doing quality checks, assembling documents for submissions, etc. With the demanding timelines, life science companies always rush for timely submissions. Across the globe, Regulatory bodies are gearing up to adopt recent developments like eCTD v4.0 for dossier submissions, amendments, and other reports.

eCTD has turned into a standard norm for industry-wide submissions in a majority of regions across the globe. It provided a single standard for the electronic transmission of submissions data and enabled the industry to communicate and exchange information with Health Authorities harmoniously.