Regulatory services, documents and data management

Regulated processes

 

We analyse, update and at times create a number of different processes with our clients. These processes are generally of three types:

  • Cross-functional reglemented processes related to R&D activities and the associated Divisions/Sites
  • Targeted processes in a given range of activities
  • Processes associated with the functional intercation between Business and IT Divisions.

 

These processes are supported by information systems that ensure that they run smoothly. A joint analysis covering both the information system and processes is therefore warranted in the following cases:

  • When preparing for imminent guideline(s) (examples: eCTDs, trial master files, Q8/Q9/Q10, risk management plans and more genrally proactive safety, DSUR inspections)
  • When dealing with functional gaps identified in the product value chain (for example: poor use of electronic document management systems, incomplete standardisation of key data, incomplete reference system, for example, the reference system for tracking regulatory activities).
  • When providing support for the implementation of organisational chnage in functional procedures (example: changes in corporate/subsidiary relationships, decompartmentalising the different specialities within a development project approach, relationshiips with third parties and outsourcing considerations, medical communication and traceability).

 

Our expertise can be divided into three areas:

  • Anticipating trends in terms of guidelines and requirements in order to implement the required changes in the relevant processes/information system. Critically assessing current processes and providing feedback on typical problems we have encoutered before.
  • Analysing this information against the pragmatic challenges and constraints facing the company. Conducting an analysis of the relevant risks, priorities and key performance indicators.
  • Formally defining the desired change to be made to current practises, working with the key stakeholders within the company, and firmly tying each change to one or more supporting information systems, where possible. Testing these "new processes" on a pilot system, providing feedback, finalisisng the processes and supporting the client in implementing the relevant change.

 

We do this using different methods, each based on the numerous assignments that have been carried out by our consultants in various industries for the past fifteen years, and in the pharmaceutical sector in particular for the past 10 years.

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