Custom framework for consistent, compliant global labelling

A global pharmaceutical organisation with a strong presence in the US market sought ICON’s help to design an end-to-end regulatory labelling process for their growing organisation. The client had a series of existing labelling process for specific tasks. Their goal was to establish a clearly defined framework with comprehensive labelling processes, leading to a cohesive process, with clear steps and defined roles and responsibilities across key stakeholders and decision-makers. This would eliminate any possible inefficiencies in labelling content development and document tracking, delays in the approval process, and compliance risks. ICON’s Global Labelling team designed and built a scalable global operating model that would accelerate turnaround times, improve accuracy and compliance, as well as support global expansion. The client selected ICON based on a proven track record of successful collaboration and deep domain expertise in regulatory and labelling transformation.

The client was working to address several operational obstacles in labelling due to lack of infrastructure, limited process documentation, non-standardised procedures and disparate ways of working across teams and regions, making it difficult to scale operations and ensure compliance across global markets. These challenges created delays in timelines, inconsistent approaches to Health Authority submissions, and duplication of effort across regions. In parallel, ICON needed to harmonise solutions to these fragmented processes within tight timelines while ensuring ongoing project delivery was not disrupted.

ICON’s Global Labelling team deployed a dedicated team, including a project lead, end-to-end labelling experts and IT solutions specialist, to design the client’s global labelling process, governance and technology infrastructure. We analysed existing processes, identified root causes of inefficiencies and designed labelling processes that support future growth for the client. We also developed global standard operating procedures (SOPs) and Work Instructions (WIs), established governance structures, and provided IT user requirements to enable sustainable process improvements and definitive choice of an appropriate labelling IT solution.

Our Labelling team partnered closely with the client’s core team throughout the process improvement project to ensure alignment on new processes, governance frameworks, and technology enablers, enabling smooth adoption across their global and regional functions.

• Step 1: Review of current operating model 
  ICON conducted a comprehensive review of the client’s SOPs and WIs and interviewed internal stakeholders across regions and functions involved in labelling activities. This information enabled a detailed gap analysis by mapping current workflows, defining roles and responsibilities, and identifying pain points and improvement opportunities.
• Step 2: Process improvement 
  Based on the gap analysis, we developed targeted recommendations for both near and long-term implementation to address process inefficiencies, strengthen governance and improve quality documentation landscape. The recommendations also included technology landscape enhancements and refined organisational roles and responsibilities to support efficiency and scalability. ICON provided a detailed strategy for prioritising initiatives, timeline planning and change management across people, process and technology dimensions.
• Step 3: Design an end-to-end process fit for the client’s operating model
  In the final phase, ICON designed future-state global labelling processes tailored to the client’s business and compliance needs that defined standardised global workflows and governance structures as well as roles and responsibilities. From new best practices and operational procedures to forward-looking technology implementation recommendations, we created a solid foundation for a scalable, compliant and efficient end-to-end labelling model. 

In addition to the current state and gap analysis reports, the final set of deliverables established the comprehensive framework the client needed for full implementation. This included procedural documents including SOPs and WIs, process maps, custom tools and technology deliverables to support future scale.
 

ICON developed an end-to-end global labelling process, beginning with triggers for label creation and changes and progressing through Health Authority approval, product launch and distribution. The new process improved visibility and oversight through stronger data tracking and content management. Roles and responsibilities for the required stakeholders were clearly defined with a governance model to support any conflict resolution related to decision-making and approval. Furthermore, ICON plans to engage the client’s technology teams in future discussions to refine tool selection and implementation strategy. Ultimately, we provided the client with a new framework that enables consistent, compliant, and timely labelling execution across global markets.