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 difficult to obtain new Marketing Authorisation approvals, maintain regulatory compliance, and ensure competitive staff operating costs. Furthermore, a major problem that many pharmaceutical companies identify, is the inability to address local regulatory issues and monitor ongoing regulatory changes in key pharma markets. 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. In this article, we aim to describe the basic regulatory outsourcing models used by pharma companies and discuss why it is worth choosing a regulatory outsourcing strategy and what tasks are mainly considered for outsourcing in regulatory affairs.
Why choose the Regulatory Affairs Outsourcing strategy?
Reduction of excessive workload in pharmaceutical companies’ regulatory affairs department
Excessive workload due to various regulatory issues that cause workload peaks can potentially arise due to various internal or external factors, such as example product/MA related issues, changes in regulatory requirements and legislation, etc. 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 need to maintain post-marketing authorization regulatory compliance for products that are already at the market at the same time but do not have sufficient amount of personnel. In such cases, it is logistically prudent to hire regulatory affairs service providers or contract research organizations (CROs) who could provide solutions locally, supplement the current regulatory team with the right amount of workforce to implement the required projects, and overall ensure regulatory compliance.
The outsourcing option may save costs for pharma companies. In particular, the employment of a person within a company requires the payment of significant taxes in addition to his salary (pension severance pay, etc.) as well as workspace cost (office and IT equipment, software licenses, etc.). The company also has to pay a fixed salary to its regulatory department employees, regardless of the number of tasks performed or the urgent need to perform them. Meanwhile, choosing the Regulatory Affairs outsourcing strategy may prove to be more cost-effective and the budget savings can be used for alternative purposes, as pharmaceutical companies do not have to maintain internal staff and have the opportunity to pay the service providers only for the tasks that are actually performed.
If a pharmaceutical company seeks to register its medicinal product in a broad range of different countries, it must have a deep understanding of the regulatory requirements in every one of them. Often, people working within a company do not have enough knowledge to be able to ensure regulatory compliance in other countries. It is also necessary to have a thorough knowledge of the national language of the country, to be able to communicate with the national competent authorities (NCAs), and to have a deep knowledge of legal regulations.
What are mainly outsourced tasks in Regulatory Affairs?
- Local Regulatory Affairs
This task group concerns all regulatory activities requiring local knowledge and local language skills, such as regulatory maintenance of Marketing Authorisations, translations of the product information, labelling, and artwork review, promotional material review, support with local risk minimization 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 authorizations, so at this point local contact is necessary. Regulatory Affairs service providers, or CROs, 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 small differences from country to country. This is especially important for products authorized 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 that could assure these requirements are addressed, local regulatory affairs service providers are a good choice to fill in this gap. It is also important to mention that the local regulatory affairs service providers can communicate with the NCAs in the local language ensuring a quick resolution of all queries and faster approvals.
- Regulatory/ Scientific/ Medical writing
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), etc. 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 experience 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. They typically operate in the pre-and post-marketing stages. By applying to service providers, MAHs save their time and financial resources by not having to worry about staff selection, recruitment, maintenance, and their level of expertise.
- Full life-cycle submission management
Differently, from local regulatory affairs, this is a group of tasks done on the other end of the regulatory organizational 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 one and only responsible and accountable party – central regulatory hub. The central regulatory hub ensures excellent coordination of submission processes by overseeing different regions of the world 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 (renewals, variations, etc.). 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 assure eCTD publishing activities, which can allow 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, as well as time and cost savings on the affiliate regulatory team side.
What are 4 common models for Regulatory Affairs outsourcing?
1. Execution of outsourced services based on specific tasks required depending on the scope of the project
In this case, companies can outsource for particular projects. The service provider plays a key role in project management and task execution and becomes responsible for the quality of the tasks performed.
2. Increasing existing staff to meet short-term business needs
The company may require staff from a service provider to be hired for short-term cooperation. This type of model allows their employees to focus on new important changes and business development.
3. Full-service outsourcing
Such an outsourcing model is suitable for post-marketing activities, which include: renewals, PSUR’s, variations, Rx to OTC switches, MA transfers, management of product information, artwork reviews, promotional material reviews, continuous consultations on regional or local regulatory requirements, interactions with competent authorities, etc.
4. Functional submissions
This is an outsourcing model where the services purchased are needed to ensure that the medicine enters the market – in other words, pre-marketing activities, such as marketing authorization applications following different marketing authorization procedures such as mutual recognition, decentralized or national procedures.
Future perspectives of regulatory affairs outsourcing
We can already see that the outsourcing of regulatory affairs services is increasing proportionally these days, but in the future, an even bigger 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 that was seen with the clinical research outsourcing model. It is expected that pharmaceutical companies will be inclined to choose flexible collaboration and expertise, needs that can be met only by specialized regulatory affairs service providers. Also, it is expected that in the future, activities will be centralized from fragmented local service outsourcing, where the affiliate chooses to outsource locally to a particular service provider, to a fully harmonized regional or even global level outsourcing. With this reorganization of the regulatory affairs service delivery model, one service provider would be able to ensure unified-governance and international coverage.
Outsourcing of regulatory affairs is a common and increasingly popular phenomenon. Most companies in the EU have already outsourced some of their activities to service providers or CROs. However, it should be borne in mind that the service provider must ensure the excellent quality of the services provided and adhere to the deadlines set by the company. Almost all stages of product development can be outsourced to local or global service companies. Even if the company does not currently intend to outsource, it should plan and select future partners that are suitable for them. In this case, a smooth outsourcing procedure would be ensured and liability issues would already be resolved.
Insuvia as a company pride itself in providing exceptional regulatory affairs services that are delivered by best-in-class experts. We have extensive experience in the local regulatory affairs activities, regulatory dossier writing, submission preparation, and approval obtainment. We utilize our expertise and extensive local network with established health authority connections to help navigate you through the regulatory process and also 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, please contact us here: Contacts