The Starodub eCTD team was established in 2017, during the early years of eCTD implementation. Since then, we have had the opportunity to support a wide range of clients with their regulatory submissions and lifecycle management activities.
Looking back, we have successfully delivered:
• Nearly 1,200 eCTD sequences
• Submissions across 9 regions and countries
• Legacy dossiers converted to eCTD (baselines)
• Initial applications, variations, responses and renewals supported
• Hundreds of documents made eCTD-compliant
• Numerous validation errors prevented
While the numbers tell part of the story, we are especially proud of the long-term relationships we have built with the regulatory teams we have supported along the way.
Interested in learning how we can support your eCTD lifecycle management and submission activities? Visit our website at ECTD (electronic Common Technical Document) • Starodub.
