Regulatory outsourcing is not a one-size-fits-all decision. The most suitable approach depends on what the company wants to keep in-house, where external expertise brings the most value, and how much operational responsibility the external partner is expected to take.
For small and mid-sized pharmaceutical companies, regulatory affairs work does not always fit neatly into one resourcing model. At one point, the need may be temporary hands-on support. At another, it may be specialist input for a specific regulatory question or upcoming submission. In some situations, it may make sense to outsource a broader part of marketing authorisation lifecycle management so that internal teams can focus their time elsewhere.
The important thing is to choose a model that fits the company’s portfolio, internal resources, regulatory responsibilities and preferred way of working.
Which regulatory outsourcing model is right for your company
The examples below illustrate common situations where external regulatory support can add value.
| IF YOUR SITUATION IS… | A SUITABLE SUPPORT MODEL COULD BE… | HOW IT CAN HELP | WHAT HELPS THE COLLABORATION WORK WELL |
| Your RA team has the expertise, but not enough capacity | Embedded RA expert support | Adds experienced additional RA capacity without increasing internal headcount, working closely with the client’s own team | Clear role definition, access to relevant systems and documents, agreed communication channels and nominated internal contact persons |
| You need input for a defined task, such as an EU roadmap or submission plan | Project-based regulatory support | Provides targeted expertise for a defined task, with clear scope, timeline, budget and deliverables | Defined project scope, necessary background documentation, timely review and decision-making |
| Your questions or workload vary over time | On-demand regulatory support | Gives flexible access to RA expertise when needed, without committing to a fixed full- or part-time resource | Agreed working model, nominated contact persons and access to relevant information when needed |
| You want to focus internal resources on core areas | Marketing authorisation maintenance outsourcing | Helps with more systematic lifecycle management, reduces operational burden and supports in keeping products compliant after approval | Clear portfolio information, access to current MA documentation and regulatory systems, agreed decision-making process, clear communication lines and timely input on business/product changes |
| You are preparing a new EU marketing authorisation application | Full or shared MAA support | Offers structured support for the process, with clear understanding of gaps, requirements, responsibilities and submission strategy | Product data, existing dossier or development documentation, strategic input from the client, access to subject matter experts and timely decisions on key regulatory choices |
See also: Embedded expert support for RA & PV teams: a flexible alternative to hiring and full outsourcing | Outsourcing local regulatory affairs: 4 examples of tailored support in the Nordics and Baltics
Lessons from regulatory outsourcing in practice
In our experience, the best regulatory outsourcing model depends first on what the client is trying to achieve. The right solution is not always the broadest one. It is the one that fits the company’s real situation: the size and complexity of the portfolio, the experience and capacity of the in-house team, the predictability of the workload, and the areas where external support can genuinely make the work easier or more reliable.
We do not see outsourcing as an “all or nothing” decision. Often, the most practical solution is a hybrid model. The client does not need to have all regulatory expertise in-house. What matters is that strategic product and business decisions remain with the client, while the external partner brings the regulatory expertise, structure and hands-on support needed to move the work forward. At its best, this kind of collaboration can also strengthen the client’s own ways of working over time.
Outsourcing should not create distance between the company and its regulatory responsibilities. Even when an external partner manages much of the day-to-day regulatory work, the client should stay informed and involved in the decisions that affect the product, business priorities and regulatory strategy. A good partner should also help make those decisions easier by explaining options, risks and practical implications clearly.
Clear responsibilities, access to the right documentation, realistic timelines, timely decisions and open communication make a real difference. Without these basics, even a well-chosen outsourcing model can become difficult to manage. With them, external RA support can bring not only additional capacity, but also structure, continuity and experienced regulatory thinking.
Whether your requirement is temporary additional capacity, expert support or long-term marketing authorisation lifecycle management, support should be flexible enough to match the situation. At Medfiles, regulatory affairs services are tailored accordingly, working closely with clients to provide the level of support they need.
Heta Karvinen, Director, Pharma Regulatory Affairs
Heta Karvinen has worked at Medfiles since 2013. All in all, she has some 15 years of experience from pharmaceutical development, marketing application dossiers and post-approval changes. Before joining Medfiles, Heta was involved in drug product and drug substance development in the pharmaceutical industry.
She has experience from planning pharmaceutical and chemical studies needed for global marketing authorisation applications as well as the regulatory guidelines that govern such studies. Previously at Medfiles, Heta worked as a senior pharmaceutical chemical expert, utilising her skillset in various drug development projects as well as managing quality dossiers for human and veterinary medicines, post-approval variation applications and the studies required to support them. During the years, she has gained valuable expertise from active substance documentation in both the European Union and the United States. In February 2022, Heta was appointed Director of Pharma Regulatory Affairs at Medfiles.
