Services and XEVMPD

By using our services or software you can significantly reduce the risks of non-compliance because we can help you implement your systems for managing XEVMPD right from the start.

As consultants to your team, we can provide professional services that enable your company to gain expertise, choose the right solutions, and successfully implement solutions for electronic submissions as quickly as possible:

  • Objective assessment of company requirements related to the new Pharmacovigilance legislation (Article 57)
  • Provide up-to-date information related to electronic regulatory submissions including the new Pharmacovigilance legislation (Article 57)
  • Installation and validation of SW solutions for managing a product database, regulatory activities, and electronic submissions according to the requirements in Article 57
  • Training end users
  • Writing of SOPs
  • Data collection and migration of existing information and documents according to the granularity as defined in the xEVMPD 
  • Integrations with existing tracking tools, eCTD Publishing tools,  document management systems, and various databases holding regulatory information
  • Custom SW development and integrations (Documentum, Sharepoint, various databases (Oracle, Access, MS QL, Excel spreadsheets, ERP systems, etc.)
  • Advice on managing the transition from paper systems to electronic systems, including arrangements for handling legacy documents and submissions

We have a team of experienced IT and regulatory professionals.

Information about formal certificates and skills that we can provide:

European Medicines Agency (EMA)

  • Extended EudraVigilance Medicinal Product Dictionary (XEVMPD)

Microsoft

  • Microsoft Certified IT Professional - Database Administrator 2008
  • Microsoft Certified Technology Specialist - SQL Server 2008, Implementation and Maintenance
  • Microsoft Certified Technology Specialist - SQL Server 2008, Database Development
  • MCTS .NET Framework 2.0 - Web-based Client Development
  • MCTS .NET Framework - Application Development Foundation
  • MCTS .NET Framework 2.0 - Windows®-based Client Development
  • MCTS .NET Framework 2.0 - Distributed Application Development
  • Microsoft Office SharePoint Server 2007, Configuring
  • MCTS .NET Framework - Application Development Foundation
  • MCTS .NET Framework 2.0 - Windows®-based Client Development
  • MCTS .NET Framework 3.5, ADO.NET Applications
  • MCPD ASP.NET Developer 3.5.
  • MCTS .NET Framework 3.5, ASP.NET Applications
  • MCTS .NET Framework 3.5, WCF Applications
  • MCPD .NET Web Developer 2.0
  • MCTS .NET Framework 2.0, Windows Applications
  • MCTS .NET Framework 2.0, Web Applications
  • MCSD .NET
  • MCAD .NET
  • Microsoft Certified Solution Developer.NET
  • Microsoft Certified Database Administrator
  • Microsoft Certified Application Developer
  • Developing Business Process and Integration Solutions with BizTalk Server 2006
  • All certifications for Sharepoint technologies
  • Microsoft Certified IT Professional (Database developer)
  • Microsoft Certified Technology Specialist (SQL Server 2008)
  • Microsoft Certified Technology Specialist (SQL Server 2005)
  • Microsoft Certified Professional

Documentum

  • EMC Proven Professional - EMC Content Management (3)
  • EMC Documentum - System Administration Fundamentals (4)
  • EMC Documentum - Technical Fundamentals (4)
  • EMC Documentum - WDK Advanced (1)
  • EMC Documentum - WDK Fundamentals (1)
  • EMC Documentum - XML and Content Management with Documentum (1)
  • EMC Documentum - xCP Advanced Training (1)
  • EMC Captiva Dispatcher Fundamentals and Development (1)
  • EMC Captiva IA Development with VBA (2)
  • EMC Captiva IA Fundamentals and Administration (2)
  • EMC Captiva System Administration (1)
  • EMC Centera Installation and Maintenance (2)

Oracle

  • Oracle Database 10g Administrator Certified Professional
  • Oracle 9i, Oracle 8i, Oracle 8, Oracle 10g, 11g, SQL*Plus, PL/SQL.
  • Oracle Designer, 9i, 6i, 6.0
  • iAS 9i 1.0.2, 9.0.2, 10g
  • Oracle Forms 10g, 9i, 6i, 6.0, 5.0, 4.5
  • Oracle Forms Server 10g, 9i, 6i, 6.0
  • Oracle Reports 10g, 9i, 6i ,6.0, 3.0, 2.5
  • Oracle Reports Server 10g, 9i, 6i, 6.0
  • JDeveloper 9i
  • iSQL*Plus, SQL*Plus, SQL, PL/SQL, Java and XML
  • Oracle Database 9i, 10g, 11g
  • ABD - Business Process Modeling with ARIS Business Designer