Regulatory services, documents and data management

Friday 04 March 2011 Change management: Preparation of documents and dossiers for regulatory submissions


To adapt the business process and tools to comply with Regulatory Submission regulation updates and to increase document preparation and management efficiency.


CLIENT


International pharmaceutical company based in France. Management teams of Regulatory Affairs and Research and Development departments.


CONTEXT


The acquisition of new pharmaceutical products by the Company and the registration of existing products in new markets (Europe, US, Canada) have increased the complexity of preparing regulatory submissions.  It has become crucial to enhance the efficiency of document preparation.

In addition to this, the evolution of regulatory requirements (eCTD, Nees, Risk Management) requires the internal adaptation of document and submission format as well as processes and systems.


OBJECTIVES


All documents likely to be included in regulatory submissions must be compliant and ready for submission when approved

  • Establishment of document templates

  • Embedding  of  specific menus  into Word to improve document presentation and guarantee the correct document format

All documents must be available in one single repository with compliant audit trails and workflows  

  • Adaptation of the current Electronic Document Management System

  •  Initial and refresher training

All submissions, will be prepared in eCTD format to benefit from life cycle management

  • Acquisition of an eCTD Publishing tool


ORGANIZATION OF THE MISSION


1. Analysis of the current situation and organisation of the Company

2. Presenting good practices and target process  to Management and Staff

3. Defining the steps to the target process (roadmap) - 2 steps have been identified

4. For each step :    

  • To agree on the process

  • To define user requirements for system adaptation

  • To communicate (Management and Staff)

  • To set up KPI for progress measurement

  •  To update the SOPs and train the users

  • At the end of the step: assessment of the step and review of the roadmap


RESOURCES


1 FTE (full time equivalent) of a senior consultant during 1,5 year


RESULTS

 

  • Submission preparation easier and faster

  • Capability of managing the life cycle of  submissions

  • Reuse of documents in several submissions

  • Increased quality and harmonisation of documents

  • Common practices and system throughout R&D for Document and Submission management

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