Regulatory services, documents and data management

Regulatory Affairs

 

The requirements of electronic submission enforced by agencies (eCTD, NeeS) and the need for standardisation have a significant impact on the preparation of dossiers and the sharing of information. In order to actually manage the full lifecycle of products on the market, the existing Information System must be adapted to create a more standardised system, enabling in particular the re-use of data that have been previously created and collected.

 

ProductLife works in the regulatory field both in consulting and advisory and in the operational outsourcing of processes and support functions.

 

Developing processes and tools

To meet the key challenges facing the industry, our consultants help you to define a genuine plan for change within your organisation.

The following are examples of some of our current assignments:

  • Defining the roadmap for transition to the e-CTD standard, based on your portfolio of products, strategy and organisational structure.
  • Analysing the impact of upgrading the EDMS system and tracking tools used for regulatory activities.
  • Providing support in the selection and implementation of new EDMS tools and tracking tools for regulatory activities.
  • Reviewing the processes in place for editing documents and preparing dossiers.
  • Managing products portfolio and interactions with authorities (Regulatory tracking).

 

Feel free to have a look at our case studies, and contact us to discuss potential projects or to find out more about what we have to offer.

 

Outsourcing regulatory processes

Our team of pharmaceutical consultants and document specialists can also support you in organising the outsourcing of some or all regulatory tasks, thus enabling you to manage your project more efficiently and, meet your targets.

 

The following are examples of document-based processes and data procedures that can be outsourced:

  • Document management and preparation of dossiers for electronic submission: editing formatting and publishing of e-CTDs in a national and international context.
  • Update, migration and recovery of regulatory events databases
  • Preparation of data for physical and electronic archiving
  • Medical and pharmaceutical editing,
  • Bibliographical researches
  • Creation of templates and development of computer-aided editing tools
  • Management of contracts with third parties
  • Processing of documents: scanning, OCR, indexing.

 

Examples of assignments carried out for Regulatory Affairs departments:

  • Support in the submission of dossiers in Europe, from preparing basic files to delivery of a dossier ready to submission
  • Preparation of variation dossiers at the global level
  • Archiving of large volumes of clinical dossiers
  • Monitoring the quality of managed regulatory data
  • Editing of dossiers
  • Publishing of e-CTD and non-eCTD dossiers
  • Managing exchanges with relevant authorities
  • Preparation for inspections.

Latest News

Wednesday 20.06.2012
Kostenloses Business Frühstück in München: „Regulatory Information Management System“ (RIMS)
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Tuesday 12.06.2012
Webinar France - Soumission réglementaire : nouveautés et innovations Démonstration SharePoint
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Wednesday 06.06.2012
Congres Montpellier: Rendez-vous au congres SFSTP 2012!
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