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Serialisation of Pharmaceutical Production

Fast, Flexible, High Quality and On Budget

BACKGROUND

  • To fulfill regulatory requirements in regards to Directive 2011/62/EU and other similar legislation worldwide

  • Full supply chain coverage: own sites, CMO’s & distributors

  • IT systems upgrade (SAP integration)

Benefit

  • Implementation of Serialisation in compliance with authority requirements

  • Implementation of Serialisation on time at multiple production sites / CMO’s

  • Coordination/Interaction with key stakeholders ✓ Deliver within budget

  • Scope changes absorbed within timeline (M&A impacts)

Services

  • Project management

  • Specification of serialisation and aggregation equipment for packing lines

  • Procurement and contract management

  • Implementation of Anti Tamper Device (ATD) on each Sales Unit

  • Validation and qualification of equipment, packaging materials and print • Documentation and hand-over to line-ofbusiness

  • Coordination with client staff: user representatives, EHS, logistics, technical specialists, procurement, finance, IT, QA etc.

CONTACT FOR THIS CASE

Thorbjørn Steensen

Mobile: +45 3048 1637
Email: thor@amgroup.dk