Integrated Regulatory Outsourcing or REG FSP?
Traditionally, functions such as Regulatory Operations would be retained in house with permanent staff within a bio-pharmaceutical organisation.
Our integrated regulatory affairs outsourcing model allows separation of core/non-core capabilities within your company allowing you to choose providers specialising in a discipline e.g, report publishing and post approval submissions have emerged as logical candidates for regulatory outsourcing due to the nature and volume of this work.
Regulatory Professionals integrated model additionally allows you to retain functional control, have confidence in staff retention, lower cost and allows greater flexibility.
This removes the burden of employment and often reduces day-to-day management requirements but has the benefits of strategic control and direct integration within functions of your business.
The need for Regulatory Outsourcing
REG – FSP services offer benefits such as increased productivity, flexibility of workforce and cost saving. There is also an ability to work real-time, with expert regulatory knowledge a distinct advantage over traditional full service CRO.
Two examples are:
1. Scalability of workforce
Within an integrated model, you are provided with dedicated resource to utilise as you wish across lifecycle demands.
Resource requirements can change rapidly up or down, and the integrated model is ideally suited to this. Should you quickly need to upscale your regulatory requirements, we have the largest Regulatory staffing division in Europe with over 50 dedicated sourcing specialists delivering REG – FSP talent to find the regulatory staff you need.
When staff numbers need to be decreased, FSP models allow clients to reduce resource simply and effectively without HR or contract burdens. Additionally for strategic roles we are on hand to provide permanent regulatory employees.
2. Seamless Integration
Our integrated regulatory outsourcing model will plug directly into your regulatory management system leaving you in control, but with the flexibility to meet legislative requirements with optimum resource linked seamlessly to your systems and processes. This allows you to collaboratively review data with us in real time during the lifecycle process.
We also operate a comprehensive performance scorecard to control quality and productivity levels, ensuring all regulatory requirements are expedited efficiently, on time and with minimal clarification.
Critical Success Factors
There are a number of indicators for critical success, such as cultural fit, proven regulatory functional expertise plus relative size and capabilities of the Regulatory provider in comparison to the sponsor’s needs.
A sponsor often has a view that in regulatory outsourcing they are choosing an FSP provider, our view is based not on an FSP approach but on expertise in Integrated Regulatory Outsourcing.
The reason for introducing an FSP model is often driven by time and workforce efficiencies rather than by cost.
However, these efficiencies create immediate cost savings such as the workforce being of the appropriate strength versus the workload required.
The more significant but indirect cost saving is the time efficiencies which means it is possible to get a drug to market sooner.
It is often perceived by Study teams that an outsourced partner will create more work. In fact, with a small amount of internal business process engineering, you will have one point of contact to streamline the process.
The Sponsor’s study teams would design the protocol and then leave the resourcing and process management to the Regulatory Professionals team who in turn can provide continuous updates and real-time data. Supported by our performance scorecard, this creates a powerful service and partnership.
Who are REG FSP?
Since 2006, we have been experts in delivering FSP projects to our partners. Our focus is on speciality teams of under 100 people. With traditional CRO’s focusing on very large global teams our customers wanted bespoke and cost effective solutions seamlessly integrating into their management structure, with a provider who valued their small scale FSP requirements, understanding the need for specialisation.
We focus on teams from 2 – 100 people, often with highly specialist requirements with a core focus on post market maintenance, we also have capabilities in Orphan Drug, Oncology, and emerging market access.
We have a track record of running International Regulatory FSP teams supported by additional resources where appropriate.
We are not a full service CRO but instead our FSP model has the capabilities to deliver a specialist, flexible, targeted and efficient solution without the high costs associated with traditional CRO services.
With teams based in over 15 countries our expanding network is designed to meet the needs of our international regulatory clients.
With staff turnover in traditional CRO’s in excess of 25% we have a track record on working to within 10%. Giving our customers knowledge that they have consistency.
Contact Regulatory Professionals
To find out more about Regulatory Professionals’ Integrated Regulatory Outsourcing solution, contact a member of our team at firstname.lastname@example.org or call us on:
UK Regulatory Outsourcing Team: +44(0)118 952 2797
EU Regulatory Outsourcing Team: +44(0)207 822 1717
German Regulatory Outsourcing Team: +49 (0)711 222 54 403
Belgium Regulatory Outsourcing Team: +32 (0)2 892 3993