Asphalion provides dossier publishing, regulatory operations, eCTD Publishing and eSubmissions services for human and veterinary drugs across multiple regions: EU, UK, US, Canada, Switzerland, GCC, and more.
For electronic dossiers, like eCTDs, our experienced e-regulatory specialists work with the latest software and our project managers use our self-developed project management tools to guarantee compliance with critical submission timelines.
Many of our regulatory experts have decades of experience providing support for all types of regulatory procedures and all types of dossiers. If needed, we liaise with agencies and overcome all potential hurdles, making Asphalion your partner of choice for even the most challenging regulatory submissions.
Asphalion provides dossier publishing, regulatory operations, eCTD Publishing and eSubmissions services for human and veterinary drugs across multiple regions: EU, UK, US, Canada, Switzerland, GCC, and more.
For electronic dossiers, like eCTDs, our experienced e-regulatory specialists work with the latest software and our project managers use our self-developed project management tools to guarantee compliance with critical submission timelines.
Many of our regulatory experts have decades of experience providing support for all types of regulatory procedures and all types of dossiers. If needed, we liaise with agencies and overcome all potential hurdles, making Asphalion your partner of choice for even the most challenging regulatory submissions.
Regulatory Operations, eCTD Publishing and eSubmissions Solutions
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Why Asphalion?
At Asphalion, we have been at the forefront of electronic submission of regulatory information since the introduction of eCTD. As a result of our flexible support and dedicated project management, we can produce high quality submissions within critical timelines.
We offer eCTD services since 2008 and nowadays managed over 4.500 eCTD sequences per year. Our eCTD publishing and submission track record includes multiple CPs (20+), as well as submissions to FDA (200+), Health Canada (40+), GCC authorities (30+), etc. We have gathered over 50 clients in the eSubmission publishing tools, managing their tool maintenance: installation, validation, training and more.
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