Regulatory Affairs Outsourcing Considerations

The pharmaceutical market is rapidly evolving and changing. Many pharmaceutical companies are facing cost pressures and workforce spin. Recent trends show that it is much more challenging to obtain new Marketing Authorisation approvals, maintain regulatory compliance, and ensure competitive staff operating costs. Furthermore, many pharmaceutical companies identify the inability to address local regulatory issues and monitor ongoing regulatory changes in crucial pharmaceutical markets as a significant problem. Whilst observing the market situation and seeing that the trading situation in the pharmaceutical business is tightening, the key decision-makers of pharmaceutical companies and biotechs are increasingly considering the possibility to obtain external regulatory affairs services from regulatory affairs service providers, in other words, to outsource. This article aims to describe why it is worth choosing a regulatory outsourcing strategy, what tasks are mainly considered for outsourcing in regulatory affairs, and the future perspectives of RA outsourcing.

Why choose the Regulatory Affairs Outsourcing strategy?

• Reduction of excessive workload in pharmaceutical companies’ regulatory affairs department.

Due to various regulatory issues that cause workload peaks, extreme workloads can arise because of internal or external factors, such as product/MA-related issues and regulatory requirements, legislation changes. Moreover, the excessive workload can be caused by overly ambitious company goals. For example, if the company wants to register many new medicinal products and needs to maintain post-marketing authorisation regulatory compliance for products that are already on the market simultaneously but do not have enough personnel. In such cases, it is logistically prudent to hire regulatory affairs service providers who could provide solutions locally, supplement the current regulatory team with the right workforce to implement the required projects, and overall ensure regulatory compliance.

• Region-specific or country-specific expertise

If a pharmaceutical company seeks to register its medicinal product in a broad range of different regions or countries, it must have a deep understanding of the regulatory requirements in every one of them. People working within a company often do not have enough knowledge to ensure regulatory compliance in other regions or countries. It is also necessary to have a thorough understanding of the country’s national language, which helps communicate with the national competent authorities (NCAs) and have a deep knowledge of legal regulations.

• Cost-effective choice.

The outsourcing option may save costs for pharma companies. The company has to pay a fixed salary to its regulatory department employees. Meanwhile, the Regulatory Affairs outsourcing strategy is a flexible option that allows you to pay only for the tasks performed. Going even further, specialised regulatory affairs experts have the necessary qualifications to perform tasks significantly faster than employees who are confronted with these tasks infrequently. Also, the company will not have to worry about staff changes, which depend on the projects and their scope. All this will help the company save in terms of costs and use the budget savings for alternative purposes.

What are mainly outsourced tasks in Regulatory Affairs?

• Regulatory/ Scientific/ Medical writing and authoring

The most often outsourced activities in this group of services are clinical & nonclinical overviews and summaries, addendums to clinical overview, expert reports, scientific publications, preparation of Clinical Trials Protocols, Investigator’s Brochure, PSURs, Clinical Study Reports (CRSs). To provide these tasks, service providers are most often approached by MAH due to the company’s current lack of internal resources, experience, and expertise. A medical writing professional with expertise in this field excels in consistency, clarity in writing, persuasion, project management, and mediation skills. Medical writers are often involved in several stages of product development, and they typically operate in the pre-and post-marketing settings. By applying to service providers, MAHs save their time and financial resources by not worrying about staff selection, recruitment, maintenance, and their level of expertise.

• Local Regulatory Affairs

This task group concerns all regulatory activities requiring local knowledge and local language skills, such as regulatory maintenance of Marketing Authorisations, product information translations, labelling, artwork review, promotional material review, and support with local risk minimisation measures (educational materials or DHPC). Many international pharmaceutical companies do not have personnel with the required local language knowledge and language skills in each country where they have marketing authorisations, and a local contact is necessary. Regulatory Affairs service providers provide the local language knowledge required for these tasks. Also, talking about regulatory maintenance of MAs in different countries, support is sought from local regulatory affairs service providers to understand and navigate through national regulatory requirements that, as a rule, have slight differences from country to country. This support is vital for products authorised in single markets via the National Procedure, which falls under the jurisdiction of a single competent authority. While it is difficult for pharma companies to maintain affiliate regulatory affairs offices in all markets to address these requirements, local regulatory affairs service providers are an excellent choice to fill this gap. It is also important to mention that the local regulatory affairs service providers can communicate with the NCAs in the local language, quickly resolving all queries and getting faster approvals.

• Complete life-cycle submission management.

Unlike local regulatory affairs, this is a group of tasks done on the other end of the regulatory, organisational structure – the regional regulatory hub. Most pharmaceutical companies strive for a unified system throughout the product life-cycle and the ability to trace all the details of the submission management they care about throughout the process. For this reason, service providers are most often asked to provide this group of services. A unified system is most commonly ensured through only one responsible and accountable party – the central regulatory hub. The central regulatory hub coordinates submission processes by overseeing different world regions and being the primary and final reference point for the local regulatory departments. They produce dossiers and submission packages for new MAs or post-approval submissions ( i.e. renewals, variations). They follow all submissions processes, progress, approvals, and product-life cycle in different countries, assuring that a pharmaceutical company has an up to date oversight of dossier and product status in each territory. The central regulatory hub can also secure eCTD publishing activities, allowing pharmaceutical companies to save costs on eCTD software licences since those are needed only in one place. Accordingly, the central regulatory hub can ensure a unified system throughout the product life-cycle, detailed oversight, compliance, and time and cost savings on the affiliate regulatory team side.

• Future perspectives of regulatory affairs outsourcing

We can already see that the outsourcing of regulatory affairs services is increasing these days proportionally, but in the future, a significant and sharper breakthrough in the growth of this group of services is expected. The growth trend in this service area can also be compared to the increasing need for the clinical research outsourcing model. Pharmaceutical companies will likely choose flexible collaboration and expertise, which can be met only by specialised regulatory affairs service providers. Also, it is expected that in the future, activities will be centralised from fragmented local affiliate-level outsourcing, where the affiliate chooses to outsource locally to a particular service provider, to a fully harmonised regional or even global level outsourcing that will help pharmaceutical companies centralise regulatory affairs operations. With this reorganisation of the regulatory affairs service delivery model, one service provider would ensure unified governance and international coverage.

Insuvia, as a company, prides itself in providing exceptional regulatory affairs services that best-in-class experts deliver. We have extensive experience in the local regulatory affairs activities, regulatory dossier writing, submission preparation, and approval obtainment. We utilise our expertise and extensive local network with established health authority connections to help navigate you through the regulatory process and bring products to market as efficiently as possible.

If you have any additional questions or need our help in Regulatory Affairs on a global or local scale, don’t hesitate to contact us.