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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 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

VCLS Expertise