Preparing for the Affiliate-Based Outsourcing for Regulatory Affairs

Affiliate-Based Outsourcing (ABO) model for regulatory affairs works as a replacement or an extension of the company’s internal local regulatory resources, which often do not fully fulfil the needs for the effective organization, flexible resources, business continuity, cost optimalization and high-quality execution of regulatory activities. One of the most essential prerequisites for the successful implementation of the ABO model is the company’s readiness for this change. This article reviews the crucial steps and practical tips on how to prepare for affiliate-based outsourcing for regulatory affairs.

What is the affiliate-based outsourcing (ABO) model for regulatory affairs?

The affiliate-based outsourcing model fills the gaps in your missing local regulatory affairs resources and/or expertise throughout your global or regional areas of operations. The model works by partnering with a trusted service provider, which becomes becomes part of your local team. The extended team can smoothly establish the missing internal regulatory framework, absorb peaks of the workload and execute all needed local regulatory affairs operations.

The affiliate-based outsourcing model provides you with adequate local resources while optimizing costs depending on your actual needs as it can be easily expanded or scaled down. Thus, it is a solution to increase the business continuity as well.

Milestones on the journey to the affiliate-based outsourcing model for regulatory affairs

The journey towards the successful implementation of the functional ABO model consists of five steps:

1. Identification of triggers
2. The preparation for outsourcing
3. Start/Roll-out of activities
4. Pilot
5. Steady state

First, the triggers for the ABO model must be identified and analysed. The triggers themselves determine the target goals for externalizing regulatory affairs operations. The further essential step is preparation. The success of affiliate-based outsourcing itself highly depends on it. The start of the first activities and piloting can be introduced only after proper preparation is completed. Thus, the focus should be directed to the triggers and the preparation steps for the affiliate-based outsourcing as they are the key base for reaching a successful steady state.

Triggers for the affiliate-based outsourcing for regulatory affairs

The triggers for the ABO closely intertwine with the benefits of such outsourcing. They depict the needs of pharmaceutical and biotech companies which turn into advantages if fulfilled. The primary seven triggers or needs are as follow:

1. To optimize the costs
2. To improve business continuity
3. To harmonize the processes
4. To improve quality
5. To extend the needed expertise
6. To have the flexibility of local regulatory resources according to your needs
7. To establish efficient project management and oversight

There is a primary trigger identified for many pharmaceutical and biotechnological companies, accompanied by an additional one(s).

Usually, one of the key targets is cost optimization, followed by business continuity improvement, which is imperative for smaller companies or companies which are quickly and vastly expanding their portfolios. In the case of portfolio expansion, there might be a need for additional expertise as an internal one may not be sufficient. Finally, the necessity for having the flexibility of resources can be a trigger causing the start of affiliate-based outsourcing.

Preparation for the affiliate-based outsourcing for regulatory affairs

What exactly does it mean to prepare for affiliate-based outsourcing for regulatory affairs? A good plan is necessary to start outsourcing smoothly. Here is a checklist of the key preparation steps:

1. Identify the company’s actual needs
2. Decide which areas of outsourcing to choose
3. Plan the internal organizational changes with a focus on the regulatory affairs team’s modifications
4. Make sure you are internally ready, including the IT/technical readiness if needed
5. Identify the fitting service provider(s)
6. Create outsourcing models that would fit your needs
7. Make sure your internal stakeholders are co ready for the changes in regulatory affairs support
8. Get ready for the roll-out of the first processes

1. Identification of the company’s actual needs

Weak points and deficiencies

First, the company must complete an analysis of the internal regulatory processes and afterwards identify the points for improvement. It’s a must to execute the analysis in detail and carefully because only then you can determine the points where the service provider can help and bring additional value.

Internal organization

Evaluation of the present local RA team and further targeted design is also needed. A very frequent approach observed in practice is that strategical regulatory functions are kept within the company while the purely operational regulatory part is outsourced. Furthermore, it’s important to also evaluate the split of the responsibilities and understand the needs of the internal stakeholders for regulatory support.

Current and future projects

Next is analyses of the current and future planned regulatory projects connected to forecasting of the resources and any tools needed. It’s important is to keep in mind the budget, so it’s under control.

Technical organization

Determine what specific systems your regulatory affairs team is using, e.g., documents repository system, regulatory intelligence system, packaging update system. Decide whether you will outsource the update/management of your systems and let the partner take over the responsibilities or keep them in-house updated by your internal people.

Regions or countries and specific needs

Region(s)/countries to be involved in ABO must be identified. For such us region(s)/countries, any special needs and/or legal requirements should be subsequently considered.

2. Choosing the areas of outsourcing

Typical key points to be evaluated to define the scope of the services are as follows:

1. The company can choose to outsource its portfolio as a whole or just part of it.
2. The service provider can be used either as an extension of your regulatory team or can replace it.
3. Regulatory affairs systems can stay in-house or can be outsourced.

A further aspect to keep in mind is deciding if the full life cycle management outsourcing can be advantageous for the company, or if the company needs support only for certain procedures/projects.

3. Internal organization / regulatory affairs team changes

After deciding what exactly will be outsourced, the next step is to prepare the internal regulatory affairs team:

• Identification of what particular roles the company needs to extend or replace from the current local regulatory team.
• Identification of strategic regulatory roles that need to be kept within the company and how they can be optimized.
• Evaluation of what is the most beneficial way to interact with the service provider.

4. Internal company readiness

Clear communication within the company about the scope of local regulatory services to be outsourced must be established to align the processes with other activities/functions which are connected to regulatory affairs. All timelines and plans have to be taken into consideration and prioritized to start the collaboration with a service provider successfully.

The other aspect of internal preparation is to set up the service provider management. And finally, it’s necessary to evaluate the company’s IT system set-up and its interface with the IT system of the service provider as applicable for the scope of the project.

5. Identification of the fitting service provider(s)

Selecting the partner is a crucial step in effective outsourcing. It is important to determine whether the company will go for more service providers for different operations or regions or choose one service provider to keep a centralized overview and ease the service provider management process.

Success to choose the most suitable and beneficial service provider is based on the clearly identified scope of the services and priorities for the local regulatory outsourcing in the submitted RFP.

6. Model fitting the needs (modelling/drafting)

Such us roadmap should provide a clear overview of the split of the roles between the parties/functions and their responsibilities. It should also contain a checklist for the handover of chosen RA activities and countries, the definition of timelines for subsequent milestones and relevant meeting slots on the journey to ABO (start, pilot, waves, steady state) needs to be set.

The pilot state is usually also designed in this point when a smaller scope of countries (1-3) and key services are usually chosen to test the targeted outsourcing model.

7. Readiness of the internal stakeholder’s/stakeholders’ management

A good relationship should be developed between the internal company stakeholders and the regulatory affairs service provider to ensure that all solutions are working for the company effectively in the practice. As a prerequisite is thus to involve internal company stakeholders from the beginning of the ABO planning to discuss the need for regulatory support, present set-up, upcoming targeted set-up considering the scope and split of responsibilities.  Stakeholders should be continuously updated about the ABO implementation status.

8. First processes

To start the ABO project on track it is important to identify high-level processes for the roll-out and pilot phase. Their aim is to describe the split of the roles and responsibilities between the company and service provider, describe operational RA processes (also potentially references on the relevant company SOPs) and define the communication flow.

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A critical element for the successful affiliate-based outsourcing model for regulatory affairs implementation is the company’s readiness for it. The key elements for the proper preparation for the ABO are identification of the needs and triggers, preparation for the journey towards the target model and checking the internal readiness for accurate preparation. Then the company gets adequately ready to roll-out the outsourcing of regulatory operations.