eCTD Publishing and Submission services
VCLS assists life science companies to streamline the entire submission process from preparing eCTD compliant files to publishing and submission.
With a global team of qualified publishers and a state-of-the-art publishing software, we effectively and efficiently manage your specific regional or global submission requirements to ensure a timely delivery. The eCTD publishing for regulatory filing can be a time-consuming task which can result in a delay of the potential submission date. VCLS is a “one-stop shop” to streamline and optimize your entire document creation value chain.
VCLS provides guidance on publishing strategy and submissions and support for the following types of applications:
- US Investigational New Drug Applications (IND)
- Global and Regional Marketing Applications: MAA, NDA, BLA, ANDA, NDS
- Post-Approval : Amendments, Renewals, Variations, PSURs etc.
- Technical Baseline Applications
- Redacted Documents in accordance with EMA Policy-070
- Active Substance Master Files (ASMF) and US Drug Master Files (DMF)
- NeeS applications
Publishing support includes:
- Assistance with identification of Regional requirements
- Formatting Microsoft Word files
- PDF rendition to eCTD compliant files
- Bookmarks and inter-document linking
- Technical Validation
- Full technical Quality Control (hyperlinks, bookmarks, metadata )
- Delivery of a technically compliant dossier in accordance with ICH Specifications and Regional Validation Criteria
- Submission Management: FDA Gateway, EMA Gateway, PSUR Repository, CESP, CD/Paper