Outsourced Regulatory Department

12 October 2018

Case Studies






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Sometimes there is sound logic for a pharmaceutical company to outsource a significant part of their regulatory tasks to a stable and experienced team. Diamond Pharma Services has been a trusted resource for a variety of companies looking to:

  • Overcome a significant workload increase
  • Place regulatory lifecycle management in safe hands whilst internal reorganisations take place
  • Increase workflow efficiency
  • Keep internal headcount to a minimum in small generics pharmaceutical companies
  • Support non-EU pharmaceutical companies entering the EU market.

Diamond Pharma Services can build a bespoke regulatory team for any company and provide a reliable regulatory workflow with appropriately qualified staff available for each task. The outsourced model can work as either dedicated FTE or task-based contracts.

 

OUR CASE STUDIES

Top 100 Pharmaceutical Company:

  • Fully outsourced regulatory department provided to support major corporate restructure.
  • Team assembled with 1 director, 2 managers and access to 5 officers.
  • 2 year project.
  • Full control of a portfolio of products.
  • Provided a safe harbour for product licences and lifecycle maintenance during a restructuring exercise.
  • On completion the client retained Diamond for Regulatory Department Overflow services.

Mid-sized UK Based Generics Pharmaceutical Company:

  • To provide outsourced regulatory services for MAA and post- marketing variations. Assistance for in-licensed products providing regulatory strategy and associated lifecycle and transfer of ownership management.
  • Long term project leader with access to regulatory pool of staff.
  • Ongoing long term project (4 years+).
  • Cost-efficient and flexible resource providing full regulatory support to several national markets.
  • Ad hoc regulatory trouble shooting for complex and urgent regulatory issues.
  • Keeping products on the market in the face of challenging situations.

Outsourced department case study for a top 100 Pharma company:

Outsourced department case study for a top 100 Pharma company:
12 October 2018

Case Studies