Outsourced Regulatory Department

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:





Case Study

ATMP Regulatory Support

The team at Diamond Pharma Services has world class regulatory experience in assisting companies developing advanced therapy medicinal products (ATMPs). Support can be provided for both cell and gene therapy products for Europe and the US.

Case Study

Clinical Trial Application Service

The CTA team at Diamond Pharma Services is integrated into the Regulatory Development Department. The team has extensive experience in CTA activities for a wide range of product types.

Case Study

Compliance And Quality Division

Diamond Pharma Services offers GMP and GDP compliance services from clinical development to commercial distribution of the products’ lifecycle.