ESPL Regulatory Consulting

Publishing

As part of our full-service offering, our dedicated publishing team can publish and maintain your e-CTD for EU and US submission, including ASMFs / DMFs and CEPs.

ESPL’s in-house publishing team, led by our submissions manager Diane Wood, supports clients with:

  • Pre-publishing checks:

o   Formatting and integrity checks of Microsoft Word modules.

o   OCR/Checking of scanned reports / documents.

o   Preparation of PDFs for publishing.

  • Publishing of e-CTDs and construction of NeeS directories
  • Upload / submission of applications via the various regulatory agency portals.

For more information on how ESPL can support your business, contact us via the form below, and we can arrange a consultation.

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