Friday 09 July 2010

Opening Pandora's box - a discussion on opening your Regulated systems to the outside world?

Friday 09 July 2010

“The challenges of Market Access” Marc Czarka

Friday 09 April 2010

Areas of expertise / Processes

Document Editing and Document Management

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
• Document 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 Product Life:

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

Assignments carried out by the Outsourcing division of Product Life:

• Preparing for document migration
• Creating an inventory of existing documents
• Document analysis and bibliographic research
• Scanning, OCR, indexing of document assets
• Cleaning up, sorting and formatting documents
• Migration of document databases

See case study: "Re-use of existing data, conversion to e-CTD format and implementation in EDMS"