Labeling & Packaging Process Optimization

JapanSmallForesight Group helps clients design and implement responsive and scalable labeling processes with clear end-to-end ownership and accountability. We help ensure the process has the correct controls in place to drive compliance and performance. Our consultants have the unique blend of knowledge regarding business process, organization design, change management, regulatory requirements, and technology needed to help build the supporting organization structure, governance, and technology solution.

We understand that labeling is a process that crosses many departments, including Regulatory Affairs, Operations and Manufacturing, Marketing, Sales, Drug Safety, Clinical, Medical Affairs, Legal, Quality, and Purchasing, as well as external vendors and suppliers. Our consultants will tap into their experience with both small and large life science companies to drive the transition across the entire organization and effect lasting changes. Our labeling solution is typically provided in two phases.

Analysis and Design

We work with a cross-functional team representing all the organizations that provide input or execute or receive an output from the labeling process to examine the existing organization structure and supporting technology. We analyze the process to identify issues and inefficiencies, as well as business and compliance risks. We then work with this cross-functional team to design a new process, organization and implement technology that meets support requirements.

Deliverables:

  • As-Is process maps
  • Documented process, organization and technology issues with root causes
  • Business and compliance risks
  • Guiding principles
  • To-Be process maps
  • Metrics and targets Organization charts with roles & responsibilities
  • Governance charters
  • High-lever user requirements on improved technology solution
  • Technology system selection · Implementation plan

Implementation

We work with you to implement the process, organization, and technology design. A communication plan is created and executed against to keep all the stakeholders well-informed during this transitional period. We work with our clients to build the necessary templates, supporting documentation, and job aids to ensure the organization has the right tools supporting the new process.

Deliverables:

  • Communication Plan
  • New labeling process implemented
  • Support documents, templates and job aids
  • Policies, SOPs and WIs
  • Functioning Governance Model
  • Operational new organization structure
  • Metrics Dashboard
  • Technology Solution
  • Training material and delivery