Welcome to
Publish Concept

Senior eCTD submission specialist


Services provided

Regulatory publishing

Documentary treatment,
Publishing, submission and support


Regulatory tools
(RIM - Publishing - eCTD)

Tool presentation,
Creation of training materials,

Consulting and Project Management

(Pharmaceutical Regulatory Affairs)

Project initiation,
Preparation and planning,
Implementation and execution,
Closing of the project

  • Construction of regulatory files
    • Support for the construction of the initial dossier (MA) and post-MA submissions, in compliance with the regulations in force,
    • Formats : eCTD, NeeS, Papier,
    • Regions : Europe, US, Australia, Canada, GCC (Gulf States), Switzerland, …
    • Resuming the life cycle of existing files
  • Documentary treatment
    • Compliance of the documentation with the functional specifications (granularity) and technical specifications in force
    • Quality control
  • Regulatory publishing
    • Assembling unit documents in a regulatory structure (depending on the region)
    • Definition of eCTD operators, based on content
    • Hyperlinking within and between documents
    • Delivery of the dossier and its technical validation reports
  • Submission
    • At the client's request, submission via the European portals (CESP and Gateway)
    • Training in the use of portals
  • Support
    • Functional and technical
    • Pedagogy on the dossier/document life cycle and the use of the eCTD
  • Identification of the learning audience and the tool to be presented
    • Level of knowledge
    • Interest in the tool
    • Language of training
  • Creation of training materials
    • Paper and/or video
    • Operating manuals, procedures, instructions
  • Planning and Organisation
    • Carrying out invitations, reminders
    • Preparation of a structuring programme
    • Identification of material and knowledge requirements
  • Conducting training courses
    • Face-to-face or distance learning
    • Ice breaker
    • Validation quiz
    • Evaluation questionnaires
  • Example of formats
    • Submission by CESP, for MRP or worksharing
    • Using the RIM Veeva Vault submission module
    • Publishing with eCTDmanager
    • How to use an eCTD viewer?
  • Project initiation : holding a kick-off meeting to clarify the request and specify the objectives,
  • Preparation and planning : identification of timelines, costs, resource requirements and deliverables,
  • Implementation and execution : accompanied by continuous monitoring and supervision to avoid time overruns and off-topic,
  • Closing of the project : Handover of deliverables and feedback.


Publish Concept is a SASU (Société à Action Simplifiée Unipersonnelle) of services specialised in pharmaceutical regulatory affairs, founded in March 2022, by Sandrine RAFFENAUD, senior eCTD specialist.
During the 14 years spent as a Regulatory Publication Officer for a major French pharmaceutical company, Sandrine RAFFENAUD has acquired solid skills in the regulatory environment such as :
  • A perfect command of regulatory publication and all related steps (publication of several thousand files, all regulatory procedures and activities combined, in many regions and different formats),
  • Support for regulatory affairs officers in the submission strategy (MRP start, Repeat-use, Worksharing) thanks to recognised regulatory expertise,
  • Support for the writing professions to produce eCTD-ready documents (formatting using word templates, placing hyperlinks)
  • Administration of regulatory databases and maintenance of associated tools, including the publishing tool,
  • Planning and management of regulatory projects.
By creating Publish Concept, Sandrine wants you to benefit from her expertise and know-how as well as the following qualities that characterize her:
  • Taste for challenge and self-investment
  • Availability, reactivity and ability to anticipate
  • Rigour and perfectionism



30 lotissement le Caroubier 31860 LABARTHE SUR LEZE - FRANCE

Phone number

+33 6 12 11 79 29



Siret : 911 103 869 R.C.S Toulouse