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    Pharmaceutical Company

Regulatory Affairs
(France)

appr. 20

Employees

Team SCALA

2

Consultants

Time Period

5

Months

Fast Track to Excellence® (Analysis & Design) in the Regulatory Affairs Department of a French Subsidiary

Starting Point

  • The Regulatory Affairs department of a French subsidiary in the radiopharmaceuticals sector, which was acquired several years ago, was to be reviewed.
  • Especially, the service processes, roles and responsibilities, service offerings, work distribution and workload, and country-specific requirements of the four teams of the French Regulatory Affairs department were to be analyzed and solutions for optimization were to be proposed.

Approach

  • Identifying weaknesses and potential areas for action from the perspective of employees and customers using structured Focus Interviews (23 interviews in total).
  • Analyzing the top 4 topics “Strategy & Goals,” “Service Processes,” “Organization,” and “Leadership & Management Behavior” with the targeted involvement of employees (tools including brown paper workshops, RACI, joint team meetings, individual interviews).
  • Analyzing performance figures, cost structures and main cost drivers as well as the employee capacities and workloads.
  • Developing a to-be concept (including definition of 8 core processes, optimization of the organizational structure, definition of roles & responsibilities, introduction of leadership training and qualification measures for employees) and estimating qualitative and quantitative effects (Benefit Case).
  • Providing a concrete action plan to realize direct improvement opportunities (“quick wins”) as well as project designs for further more detailed analysis.

Deliverables/Benefits

  • Overarching strategy and target system for the French unit.
  • Targeted organizational and communication measures that can be implemented in the short term to increase the quality of results and improve collaboration (“quick wins”).
  • Project designs for improvemnts in the areas of processes, organization and management skills; expected cost savings: >250 TEUR.

Further Project References

  • Developing a Process Model according to BPMN 2.0 Standard in Clinical Development22. March 2021 - 1:34
  • FT2E® (Analysis & Design) in the Corporate Communication Department (Interface: M&A/Corporate Finance)27. March 2021 - 10:59
  • Optimizing the Clinical Development Business Process Model and transfer to a web-based Solution20. March 2021 - 19:54
  • Managing a Program for the Implementation of an integrated Data Hub for Clinical Development21. March 2021 - 18:27
  • Planning, managing and monitoring a Hardware and Software Roll-out for Fund Services & Private Banking22. March 2021 - 1:14
  • Computer System Validation of an „Adverse Event Reporting Tool“ for Pharmacovigilance22. March 2021 - 1:15

Our office in Cologne

SCALA Management Consulting GmbH & Co KG
EuroNova III
Zollstockgürtel 61
D-50969 Köln
n: +49 (0)221 / 27 64 59 82
x: +49 (0)221 / 27 64 59 83

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LAST PROJECTS

  • Developing a Process Model according to BPMN 2.0 Standard in Clinical Development22. March 2021 - 1:34
  • Developing a flexible and cross-functional Business Data Model in Clinical Operations20. March 2021 - 19:58
  • FT2E® (Analysis & Design) in the Corporate Communication Department (Interface: M&A/Corporate Finance)27. March 2021 - 10:59

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