The regulatory outsourcing landscape is changing. Cost pressures and the need to focus on innovation are prompting companies to outsource much of their post-launch regulatory compliance. At the same time, maintenance of the mature product portfolio in accordance with stringent regulatory requirements is vital to keep these products on the market and sustain the revenue stream long term.
To safeguard these important assets while minimizing maintenance costs, companies are turning to domain experts and adopting a strategic approach to regulatory affairs outsourcing. They are looking to partners to take on the regulatory maintenance of large parts of the established portfolio at the corporate, regional, and local level.
Outsourcing gains momentum
Estimates for the regulatory outsourcing market vary, with one recent source valuing it at an estimated $9.33 billion in 2025 and projected to rise at a CAGR of 10.9% from 2025 to 2032[1]. Cost savings is one important driver for outsourcing. Another is increasingly strict regulatory standards leading companies to rely on specialist partners to help them achieve compliance. These experts monitor regulatory changes and trends, which further helps companies to stay ahead of their obligations.
The move to a combination of global and local outsourcing is gaining momentum with companies of all sizes in a more complex and constantly evolving regulatory landscape.
Having access to global expertise and regulatory intelligence is an added benefit to outsourcing since it allows companies to expand market access for established products and thereby improving revenue streams.
Regulatory expertise at the local level translates into further cost savings by allowing companies to scale support as and when they need it. By outsourcing their regulatory maintenance, companies can enjoy agile regulatory expertise without the management overhead of maintaining internal teams.
Driving innovation
Innovation is a priority for companies and is why many are choosing to outsource more routine, yet critical regulatory maintenance activities. First, outsourcing allows internal teams to turn their focus on innovation, strategic growth and priority market opportunities that benefit the business.
Estimates from projects PharmaLex has carried out show outsourcing programs can deliver an estimated 20% reduction in resource due to efficiency gains by years 2-3 of the arrangement. That resource can be refocused on innovative drug development programs.
Strategic outsourcing partners drive process innovation that allows companies to achieve greater efficiencies across the entire business. They also bring opportunities to implement digital innovation across the business, including automation, artificial intelligence (AI), and cloud solutions that help to improve global collaboration and information sharing.
A combination of regulatory and scientific expertise together with advanced technological capabilities offers substantial benefits to cost-effectively manage established products from end-to-end. This allows all the critical functions to be managed holistically rather than as siloed activities, which helps to streamline operations and drive economies of scale.
Furthermore, an integrated approach lends itself to continual improvement and strengthened quality assurance, which better positions companies for future modernization – a growing imperative as health authorities increasingly adopt digital and data-driven processes. The European Medicines Agency (EMA) and Heads of Medicines Agency (HMA), for example, have published an AI workplan for 2028 for the use of AI in medicines regulation[2].
Outsourcing to a partner skilled in deploying new and emerging technologies at an enterprise level allows companies to tap into the benefits of digital transformation without needing make significant capital investments in infrastructure.
Determining the right approach
Outsourcing needs will vary depending on the size of the company, the maturity of its portfolio, the markets it is operating in, and the short- and long-term objectives.
Decisions on when and how to outsource typically begin with an assessment of existing global and regional programs. This analysis will help to identify resource capacities and identify gaps in knowledge or capabilities .
Determining the organization’s current internal resources and skills will offer key insights into where internal teams could potentially be refocused to generate greater value and increased competitive advantage for the business. It will also help companies to assess potential staffing and resources challenges. These include lack of experienced skilled staff to carry out the necessary regulatory compliance activities, high staff turnover, and sizable operational costs compared with revenue generated from established products.
Once the needs are understood, companies can begin to assess the best approach. Options include fully outsourced global management of the established portfolio, tactical engagement for specific expertise, supplements to existing resources, or one-off deliverables. Any outsourcing partnership should function as a seamless extension of internal teams. Long-term efficiencies are best achieved through tailored solutions to support critical regulatory maintenance processes. Solutions can include the application of in-country, near-shore, and offshore specialist capabilities.
End-to-end outsourcing often incorporates a blend of global regulatory support involving activities at the corporate headquarters and local or regional outsourcing, which harnesses regional or hub-based off-shoring. At the local level, in-country expertise and presence will often need to be maintained, and in some instances outsourcing partners can take on the entire regulatory affairs function at the local level.
Adopting outsourcing best practices
Regardless of the depth of the outsourcing engagement, a program management framework should be embedded in any agreement. Such a framework is most effective when led by a project leader, who has overarching responsibility for the governance, strategy and delivery of all outsourced post-approval regulatory activities.
Having one point of contact facilitates cross-functional communication, oversight of key performance indicators (KPIs), and quickly responding to the changing needs of the organization. Clear governance and oversight are imperative to ensure all stakeholders understand their roles and responsibilities. Key functional roles within such a model will typically include a formal steering committee, program managers with operational oversight, program teams and product coordinators.
Realizing the benefits of outsourcing
The benefits gained from global regulatory outsourcing are best understood through the experience of companies that have turned the maintenance of their established products over to a partner.
In one example, a large European biopharmaceutical company turned to PharmaLex more than 10 years ago, initially to handle a small number of established products at the global headquarters and later at the regional and local level. Today, support spans all aspects of regulatory affairs, including CMC, publishing and submissions activities, for an extensive range of products. All of the company’s regulatory affairs functions for its established products are now managed by a team of 150 PharmaLex specialists, and the company has reported significant workload efficiencies.
In a second example, a specialist company with headquarters in the Asia-Pacific region recently entered into a joint venture to market its established medicine brands in several major European countries and through a network of partners in additional territories worldwide.
To further optimize processes, the company engaged PharmaLex, initially for local regulatory quality work, and later for pharmacovigilance support. An experienced global program manager oversees all workstreams for the businesses, with co-ordination for Asia- Pacific managed offshore.
The regulatory compliance maintenance program has allowed the company and its joint venture to significantly reduce operational costs and focus on core competence activities.
Trust and flexibility
With more companies seeking to outsource regulatory activities for their marketed products, the emphasis needs to be on a relationship built on trust and flexibility.
A holistic approach to regulatory outsourcing creates a powerful platform for continuous innovation, process improvement, and competitive advantage. With a trusted partner, companies are better positioned to adapt to a shifting regulatory landscape, expand into new markets, and take advantage of innovative technologies to streamline processes across the enterprise.
About the authors:
Stefanie Lietsch-Dallwig is Senior Director, Local Affiliate Services at PharmaLex. She is an international regulatory affairs professional, fluent in German, English, and French, and has held several senior regulatory affairs positions in the pharmaceutical industry. Her leadership roles have included Director Regulatory International and Emerging Markets, Head of Regulatory Intelligence, and Director Project Management. Stefanie brings a demonstrated track of registration and launch planning for new applications and variations in EU and non-ICH countries.
Paula King, Director of Regulatory Affairs for PharmaLex, is an experienced program manager with 20+ years of regulatory, quality and compliance experience working in a variety of leadership roles including Pfizer, Celgene, and Parexel. She has extensive knowledge of all GxP areas and the ABPI Code of Compliance combined with extensive appreciation of the EU and UK regulatory environments, and is trained as an ISO9001 auditor.
[1] Regulatory affairs outsourcing market size and trends, Coherent Market Insights. https://www.coherentmarketinsights.com/market-insight/regulatory-affairs-outsourcing-market-2751
[2] Artificial intelligence workplan to guide use of AI in medicines regulation, EMA, Dec 2023. https://www.ema.europa.eu/en/news/artificial-intelligence-workplan-guide-use-ai-medicines-regulation
