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AIM|5 September 2022

Supply Chain Development

AIM excels in designing and developing flawless supply chains from the ground up, particularly for new market entrants and start-up life science companies.  Our supply chain development services are comprehensive and cover all key aspects of supply chain strategy, design and implementation.

AIM excels in designing and developing flawless supply chains from the ground up, particularly for new market entrants and start-up life science companies.  Our supply chain development services are comprehensive and cover all key aspects of supply chain strategy, design and implementation.

We have an extensive track record in this area, with over 60 launches supported to date.  In addition, our expertise spans all segments of the life sciences, including (bio)pharmaceuticals, controlled substances, advanced therapy medicinal Biotech products (ATMPs), medical devices, diagnostic equipment and kits, and more.

After the first launch, we also support subsequent products, regions, and indications.  Below is a high level overview of our supply chain development services along the timeline to launch (and beyond).

Preparing for Filing

  1. Select and implement contract packaging organizations
  2. Define Manufacturer’s and Importer’s Authorization (MIA) holdership and Qualified Person (QP) release
  3. Develop and execute transport validation strategy

Strategy Phase

  1. Understand supply chain needs
    • Customer Geography
    • Product
    • Price
    • Urgency
    • Home care
    • Storage conditions
    • Transport conditions
    • Legal structure
    • Financial context
    • Safety issues
    • Compliance needs
    • QP releases
    • Number of SKUs
    • Packaging strategy
    • Finish to order concepts
    • Customer Service needs (languages, complaint management, response times, service levels)
  2. Design the supply chain
    • Define product, financial flows
    • Define service levels
    • Define handovers
    • Develop RASCI responsibility matrix (Responsible, Accountable, Supporting, Consulted, and Informed)
    • Set up team
    • Define IT infrastructure
    • Define scope of partner activities
    • Define scope of in-house activities

Execution Phase

  1. Select partners
    • Prepare RFPs / RFQs
    • Evaluate bids
    • Visit providers
    • Define shortlist(s)
    • Audit providers
    • Select provider(s)
    • Negotiate commercial contract KPIs and service expectations
    • Negotiate Quality Agreements
  2. Build the supply chain
    • Create project team
    • Create steering team
    • Create project plan
    • Define pre-set gates
    • Define timelines
    • Build roll out plan
    • Define responsibilities
    • Appoint owners
    • Execute project management
    • Train team members
    • Perform change management
    • Conduct auditing / testing
    • Issue formal go-ahead
  3. Implement the supply chain
    • Provide intensive care during the go-live period (first 2-4 weeks)
    • Audit reports and interfaces
    • Verify SOP correctness and compliance
    • Provide after care to users and suppliers
    • Conduct handover

Recently, AIM hosted a webinar panel discussion that addressed the key supply chain aspects associated with launching a new pharmaceutical or biotech therapy in Europe.
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