Benefits of Outsourcing Regulatory Affairs
The developments in the market, mergers and the issues associated with pricing pressures applied by governments (such as the IPHA deal and the AMNOG deal in Germany) has caused companies to address internal issues and to seek to minimise the negative impact of the aforementioned measures. To that end, many company have begun to look at outsourcing regulatory affairs functions to companies such as Acorn Regulatory.
Growing pressures on pharmaceutical companies have seen a marked increase in the number of companies outsourcing non-manufacturing activities to third-parties. Departments such as IT, finance, facilities, procurement and property services have all seen significant changes as their operations have been moved to external service providers.
Increasingly, we are witnessing the move by clients to outsource their regulatory affairs departments. Acorn Regulatory acts as the virtual regulatory affairs office for many companies around the world. Our staff liaise with management and technical staff electronically and, when the need arises, on-site to manage liaison with competent authorities, dossier preparation, chemistry manufacturing and controls, submission publishing and planning, regulatory data management, report writing, medical writing and other tasks.
Companies have partnered with us as their virtual regulatory affairs department for a number of reasons. Firstly, they seek to draw on our market leading expertise at a cost effective rate. Furthermore, the move from an in-house cost to a flexible consultancy arrangement also sees the company reducing costs associated with full time employment such as pension, annual leave etc. The move to the outsourced department model has seen many of our clients make large savings by only having to pay Acorn Regulatory for productive consultancy hours rather than permanent employee rates. Furthermore, overhead costs associated with full time employment are eliminated.
Parallels With The Airline Industry
The 1990’s were a tumultuous time for people in the airline industry. Until then, the ‘flag carriers’ had dominated the industry. However, new entrants into the sector in the US such as Southwest Airlines and Ryanair in Europe disrupted the market and forced long established airlines to look at their cost structures. External events such as the global financial crisis of the early 1990’s coupled with an unsettled geopolitical environment forced their hands and expedited their decisions to engage with third parties. Now, it is rare to find an airline that manages catering, check-in, baggage handling and airline servicing in-house. The industry has become a champion of the benefits of outsourcing all but the core elements of its business. It is a trend that is now being mirrored by the pharmaceutical sector.
Main Areas for Outsourcing Regulatory Affairs
Right now, the most frequent requests that we handle on behalf of pharmaceutical clients focus on:
- Clinical trial applications
- Managing the processes around the maintenance of marketing applications
- Breaking in to new territories
- Transfer of wholesale distribution agreements or marketing authorisations
Perhaps one of the benefits of Acorn Regulatory being a global company with clients in every major market in the world is that we have expertise that encompasses regions, functions and products.
Admittedly, bringing a third party to the table is a progressive step on the path to efficiency and it is one that is not taken lightly. However, we work at every turn to guarantee project performance, systems/data integrity and trust between all parties.
Outsourcing is cost effective and increasingly popular. Acorn Regulatory can work with you to manage your regulatory affairs department. Talk to us today about how we can help you.