Meet our eCTD team
Ten years ago, the eCTD (electronic Common Technical Document) format was introduced as the future for regulatory dossiers. Nowadays, many health agencies are accepting this format and implementation is still expanding globally. For most of the leading health authorities, such as EU and US, eCTD is now the only accepted format for submission of regulatory filings.
At STARoDub B.V. we started offering eCTD services in 2017 and since then we have been expanding our knowledge and expertise by creating hundreds of eCTD sequences. Our activities range from preparing eCTD compliant documents, providing tailor-made advice (taking into account the latest regulatory guidance), creating and validating eCTD dossiers and submitting dossiers to health agencies. Our team has experience with eCTD creation for EU, US, Canada, Switzerland, Australia, New Zealand and South Africa. We use expert software which is updated on a regular basis.
Customers have scored our eCTD team with a 5/5, especially appreciating our “speed of delivered services, clear communication and expertise”.
Is your company facing challenges in allocating time, securing qualified personnel, or accessing the right knowledge to prepare eCTD submissions? We are more than happy to provide support. Please check our websitewww.ectd-starodub.com or contact us via Contact form.