Sterile Remediation Project

Challenge

Our client, a leading global pharmaceutical company, had a key sterile manufacturing site put into remediation following an FDA warning letter. We met with the leadership team at the site in Italy to discuss exactly what Regulatory Compliance solution they needed. Challenge

Consulting Services

Solution


Proclinical’s unique costing structure ensured we won the bid for this work exclusively by making it clear that results could be provided within-budget whilst still meeting the short time-frame. Proclinical utilized a multi-lingual delivery team to provide pre-qualified specialist support in less than 7 days. Our delivery team was exclusively committed to the project meaning they had the time to focus on every hire. Each candidate was stringently vetted for sterile experience and long-term commitment to the project. We also utilized an in-country solution to ensure each team member was mobilized, supported effectively and ready to work when arriving into the country. Thanks to an excellent partnership with the management structure at the plant, Proclinical was also able to provide a team of people for each workstream that settled in quickly and seamlessly into the existing workforce, minimizing disruption.

Outcome


  • Workforce retention rate was 92%
  • Peak headcount on the project was 34
  • Site was successfully moved out of remediation ahead of time and under budget
  • Testament to our sourcing methods, 13 consultants remain on-site to ensure best practice for prevention

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