Accovion Plus
Accovion Plus
Electronic Common Technical Document
Increasingly, regulatory agencies recommend or require the Electronic Common Technical Document (eCTD) format for electronically submitted new marketing authorization applications. This eCTD not only promotes standardization and a faster approval, it also enhances your product value through built-in life-cycle management capabilities.
Accovion’s Medical Writing and Electronic Publishing team can help you improve your communication with regulatory authorities and obtain faster approvals with a state-of-the-art, hyperlinked electronic dossier published to ICH M2 specifications. This interface for information transfer provides advantages for both you and your regulatory reviewers.
eCTD benefits for you
- Provides single repository for documentation covering the lifecycle of your product
- Facilitates updating and supplementing the submission
- Minimizes reviewer questions and time between submission and approval through consistent and thorough data presentation
- Reduces printing, shipping and resource costs
eCTD benefits for your reviewers
- Enables easy navigation through state-of-the-art hyperlinking (XML backbone)
- Standardizes data presentation for faster review
- Presents essential data for proposed product labeling including findings across studies discussed in light of current medical opinion
Integrated approach for your submission
Accovion’s services work seamlessly together to produce your submission (CTD or eCTD), from database set-up and programming through coding, statistical analysis, medical assessment, summary writing and electronic publishing. Our hands-on experience with CDISC standards and in-depth knowledge gained from active contribution to crucial guidance documents such as ICH M4 “Common Technical Document” are applied into the design, preparation and compilation of your electronic submission documentation. For more information, click here for a downloadable brochure.
Damien Lynch, PhD
Director, Medical Writing and Electronic Publishing
+49 6196 7709-301
