eCTD Management
eCTD Management: Your Marketing Authorization Lifecycle
Medipha Santé works with Extedo's eCTD Manager software, which is used by more than 35 regulatory authorities and offers a complete solution for managing and assembling regulatory files.
To ensure compliance with regulatory requirements, eCTD management allows us to maintain a comprehensive overview of submission statuses for a number of products in several different geographical markets.
Simplify your electronic submissions with our eCTD expertise
Medipha Santé assists you in creating, validating, publishing, and submitting your electronic dossiers to French, European, and international health authorities. Our experts ensure submissions comply with the latest regulatory requirements throughout the entire lifecycle of your products.
Our services
Creation and management of eCTD sequences
Publication and formatting of files (eCTD, NeeS, IMPD, CTA, ASMF...)
Filing of initial applications, variations, renewals and responses to authorities
Quality control and technical validation of submissions
Metadata and hyperlink management
Submission via regulatory platforms (CESP, eSubmission Gateway, national portals...)
Support for European, American and international cases
Why choose Medipha Santé?
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More than 200 applications are submitted each year.
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Recognized expertise with over 25 health authorities
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Submissions compliant with ICH standards and regional requirements
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Ongoing regulatory monitoring, including developments towards eCTD 4.0
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Secure support throughout the entire regulatory lifecycle