Dossier preparation, production, submission and maintenance

Documentation and dossier management and editing

 

This service can cover a number of core R&D activities:

  • Regulatory affairs
  • Clinical fields
  • Non-clinical fields (toxicology for example)
  • CMC/Quality
  • Quality assurance (SOP)
  • Pharmacovigilance

 

Client objectives:

  • GxP compliance
  • Document security
  • Document re-use and sharing
  • Docuement classification
  • Reliability and traceability versus document status and version control
  • Implementation of a (legally required) record retention strategy.

 

Assignments carried out by the Consulting division of ProductLife:

  • Project management support
  • Editing for legal and regulatory documents
  • Support in the submission of dossiers.

 

Assignments carried out by the Outsourcing division of ProductLife:

  • Preparing for document migration
  • Creating an inventory of existing documents
  • Document analysis and bibliographical research
  • Scanning, OCR, indexing of document assets
  • Cleaning u^p, sorting and formatting documents
  • Migration of document databases.

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