project

Project management for the construction of a pharmaceutical plant in Latin America

Project management Life Sciences Latin America

Project presentation

Our client is a pharmaceutical group specialised in plasma-derived and recombinant drugs. Today, it is one of the leading European players in biopharmacy, offering plasma-derived medicinal products to healthcare professionals, mainly to hospitals.

In 2011, the group sold the construction of a turnkey plant to a technology transfer company in Latin America to produce six essential medicines for human health. The fractionation capacity of the plant will be 500,000 litres of plasma per year. Studies and construction were launched and in 2015 the project was suspended at 70% completion following injunctions from the ANSM ( French National Agency for the Safety of Medicines) on the production

In 2020, a new contract was signed to finalise the works on the plant. Assystem has been appointed to manage the project.

Missions

Project management with the teams of the pharmaceutical group and the local technology transfer company:

  • Analysis of the contract and analysis of contractual risks
  • Organisation and management of the committee of the executive committee and the steering committee
  • Planning and management of the project team's missions Preparation of the budget, billing forecast and invoicing
  • Training of a team of 30 people from the technology transfer company
  • Organisation of inspections of the technology transfer company's on-site activities
  • Synthesis of the feedback from the ANSM (French National Agency for the Safety of Medicines) on the production process implemented by the technology transfer company
  • Organisation of the technology transfer

Client benefits

  • Compliance with contractual commitments (technology transfer, feedback from the national drug safety agency, team training, etc.)
  • Highlighting of contractual problems on the new contract (2020) (phasing of incoherent activities, definition of the missions of the teams prohibited by the national regulation, ...)
  • Mobilisation of a reduced team thanks to the versatility of Assystem's skills on all the themes of the project (management, inspection, process feedback)
  • Securing of the project planning by the installation of indicators and the organization of the executive committee and the steering committee
  • Improvement of the client's management vision of the project's progress and communication with the local technology transfer company
  • Keeping the contractual schedule

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