Outsourced Regulatory Consulting: Case Studies
There has been a growing market in the provision of out-sourced services to meet the demands of lean (bio)pharmaceutical operations. The provision of advice and support in the regulatory activities required to support a clinical development programme is well suited to an outsourced model. The most successful projects engage advisors able to act as an independent voice but integrated into the project team. An additional advantage of the outsourced model is that the client is able to access bespoke and sometimes niche services as and when a project needs them, without the expense of retained services that are only required on an ad hoc basis.
The situation can be slightly different in the pharmaceutical post-marketing phase where consulting organisations can offer cost effective solutions for the provision of retained regulatory services. Outsourced regulatory consultancies can offer generics and late-stage innovator companies of all sizes a stable resource to provide a safe harbour for regulatory life cycle management. This is best achieved by engineering strong partnership relationships with consultancies able to provide a pool of talented regulatory professionals. Over time this enables the chosen partner to retain expert knowledge in the regulatory history of a product enabling efficient and proactive responses to the ongoing variations and lifecycle demands for a licensed product.
Whether the product is a small molecule, cutting edge gene or cell therapy, innovator product or generic, there are cases where an outsourced pool of talent can provide strategic and commercial advantages to any virtual or multinational (bio)pharmaceutical company.
At Diamond BioPharm we are celebrating our 10 year anniversary this year. To mark this occasion we are providing 10 years of case studies. You will find in these case studies examples of how we have met the needs of a wide variety of clients from virtual to multi-national and offered a commercial advantage in each case. In the slides linked to this post you will find examples of:
- Outsourced regulatory teams where Diamond has offered a safe harbour for life-cycle management to companies of various sizes.
- Overflow regulatory support to enable clients to manage peaks and troughs in work flow.
- Support in change management, offering continuity in product life-cycle management during site transfers and organisational restructuring.
- Interim drug development director support, supporting clients towards, into and through clinical development.
- Support at the frontiers of technology, providing expert advice and guidance in complex and new areas such as gene and cell therapy
We hope that you find these case studies informative, and please feel free to contact us for further details.