Regulatory affairs support, Publishing & Submissions and Solutions for a young pharmaceutical company

Document level publishing (Word and PDF)

Compilation of eCTDs

Set up and dispatch of eCTD dossier to the FDA via the Electronic Submissions Gateway

Setting up and maintaining a file and folder structure for document authoring on Celegence premises for document authoring by client

Structuring and organizing the regulatory dossier (e.g., specifying the document granularity)

Maintaining an oversight of the dossier status

Regulatory affairs support strategical and procedural

Strategic input to document writing

Content review of documentation (including consistency and logic checks)

Strategic and procedural support (e.g., putting together material for fast-track designation request)

Contributing to pre-IND meetings

Dosscriber™: CTD templates for document authoring provided with a Style Guide and MS-Word instructions. Associated with a lean authoring training targeted at anyone involved in (CTD) document writing

Dossplorer™: providing our regulatory dossier viewer available for dossier viewing in a preliminary and final stage of the project. Within this viewing tool, the dossier can be browsed and commented on, without having to exchange the document and dossiers in time consuming manner. Associated with a user training targeted at anyone involved in the project

User access to Celegence’s server to act as eDMS for this project; using a dedicated file and folder structure on a shared drive for the exchange and maintenance of documentation