Back to BlogScaling smart: How pharma leaders can navigate compliance and growth across borders
Expanding into the EMEA region—the collective term for countries across Europe, the Middle East, and Africa—offers pharmaceutical companies access to diverse patient populations, skilled talent, and emerging markets for clinical research and innovation.
However, this geographic spread also introduces a diverse range of regulatory systems, which can make compliance a significant challenge for companies seeking to expand across borders.
This article examines how pharmaceutical leaders can navigate these complexities with a compliance-first approach. With the support of CXC’s global solutions—Employer of Record (EoR), Agent of Record (AOR), and CXC Comply—organisations can reduce risk, accelerate onboarding, and scale operations securely across multiple regions.
The EMEA opportunity and the global compliance paradox
The EMEA region presents a significant growth opportunity for pharmaceutical companies, offering a compelling mix of mature and emerging markets. Let’s paint a picture:
- Europe leads with strong research infrastructure, regulatory alignment via the European Medicines Agency (EMA), and rising demand for biologics and digital health.
- The Middle East is experiencing rapid growth due to increased public health investment and rising demand for generics.
- Africa presents untapped potential driven by improved healthcare access and growing local manufacturing. This makes the EMEA region a prime location for clinical trials, R&D, and commercial expansion.
But navigating this region isn’t straightforward, since EMEA is a patchwork of labour laws, tax regimes, and data protection rules. For example, what’s permissible in Sweden may be restricted in Saudi Arabia. A contract model used in the UAE may be non-compliant in the Netherlands.
This regulatory fragmentation constantly puts pressure on HR and legal teams to adapt in real-time. This means localising contracts, policies, and compliance processes across multiple jurisdictions—without missing a beat. Otherwise, the planned business expansion may be delayed or even halted. The role of HR and recruitment teams is more crucial than ever.
Growth potential meets regulatory complexity
Pharma leaders are particularly affected because their expansion strategies often involve high-risk and tightly regulated functions.
For example, while South Africa has become an attractive destination for late-phase trials, companies must comply with the Protection of Personal Information Act (POPIA), the country’s version of EU’s General Data Protection Regulation (GDPR). It governs how personal data is collected, used, and handled. Although similar, POPIA has local differences in how consent is defined and how data regulators enforce compliance, so companies can’t assume a one-size-fits-all approach.
Meanwhile, launching a sales team in Saudi Arabia requires compliance with Saudisation policies, which mandate a minimum quota of Saudi nationals in the workforce. Companies must also partner with a local sponsor or registered entity to legally hire and pay staff, since foreign businesses cannot directly employ workers without a legal presence.
The hidden cost of compliance gaps in pharma expansion
These country-specific requirements can complicate hiring, stretch out timelines, and create legal uncertainty if not managed carefully. Regulatory oversight is also intensifying. For example, Germany and the UK have stepped up enforcement around worker classification.
Pharma leaders who are excited to expand in EMEA may experience uncertainty when faced with the complicated requirements. However, there’s no way around it. As a result, it’s becoming increasingly complex for pharmaceutical companies to maintain consistency and avoid compliance gaps.
The cost of getting it wrong
Here’s a scenario. If a pharmaceutical company misclassifies a contractor in France—say, a clinical research associate (CRA) hired as an independent contractor but working full-time under the company’s supervision—it can trigger a full-scale labour inspection. French authorities may retroactively reclassify the worker as an employee, forcing the company to pay unpaid social security contributions, employee benefits, and penalties. In some cases, the company may be barred from continuing the engagement until compliant.
Data compliance missteps carry similarly steep consequences. Under the GDPR, sponsors handling clinical data must obtain explicit consent from participants and secure proper transfer agreements when transferring data across EU borders. Violations can result in substantial fines—in 2020 the UK’s ICO fined a telecoms company £100,000 for sending mass marketing texts without consent.
In the pharmaceutical context, mishandling clinical data could also lead to substantial fines in the hundreds of thousands of euros and significant reputational damage.
Compliance as a strategic lever
The risks of getting it wrong are clear—but the reverse is also true: getting it right opens doors.
In a sense, getting compliance right doesn’t just secure your smooth entry and expansion in the EMEA region; it also ensures your continued success. It also becomes your strategic advantage.
Aligning employment contracts to local law before entry, conducting worker classification audits, and adapting onboarding workflows to each country’s regulations can significantly reduce time-to-hire and avoid costly rework mid-project.
The same applies to data governance. Establishing strong consent protocols, secure storage practices, and local ethics approvals from the outset fosters trust with regulators and accelerates site activation, particularly in data-sensitive trials.
In short, structured compliance enables faster decision-making, smoother partnerships, and more predictable expansion across EMEA.
Onboarding delays are derailing R&D and clinical trials
Even with compliance foundations in place, many pharma companies may still face bottlenecks when trying to activate new sites. Regardless of the location, trial timelines are closely tied to funding schedules, investigator availability, and patient recruitment. But operational lags—especially during workforce onboarding—can derail critical milestones.
The urgency of rapid deployment
Delays in clinical operations often stem from slow contracting, inconsistent documentation, or limited oversight across dispersed teams. These issues are especially visible on the ground, where trial readiness depends on how quickly staff and systems can be mobilised.
In Central and Eastern Europe, for example, lower trial costs can be offset by administrative hurdles—paperwork backlogs, tax registration lags, and gaps in local infrastructure. A company launching Phase III trials in Romania might spend over a month just getting clinical research associates’ sites ready. This then pushes back timelines.
Meanwhile, in the Middle East, strict employment frameworks, such as sponsorship rules and nationalisation quotas, extend beyond commercial roles. They also affect clinical and R&D talent, requiring firms to engage through local entities or partners. Even fully funded trial sites may be stuck waiting on legal clearances before teams can begin work.
Compliance through localisation and process alignment
One way pharma companies can reduce onboarding delays is by preparing for local compliance right from the start. That means adjusting contracts, onboarding forms, and HR protocols to reflect legal and regulatory expectations in each market—before entering, not after issues arise. At the same time, standardising global workflows ensures consistency across regions without sacrificing local accuracy.
For example, Germany requires works council consultation for certain roles, which can delay onboarding if not built into the process. In Hungary, fixed-term contracts must include specific termination clauses to be valid. Addressing these kinds of requirements early helps avoid hold-ups and compliance disputes.
Managing worker classification and regulatory risk at scale
Worker classification is one of the most closely monitored compliance issues for multinational employers, particularly in highly regulated sectors such as pharmaceuticals. The industry’s reliance on specific skills and project-based professionals—like medical writers, statisticians, or data managers—means many roles sit in grey areas of labour law.
Because these roles frequently involve long-term engagements, close supervision, or integration into core teams, they often fall under the spotlight of labour authorities. And, as mentioned above, in EMEA, regulators are starting to crack down on disguised employment—targeting not just tax violations, but breaches of social security, benefits entitlements, and worker protections.
Navigating misclassification in EMEA
Even when the risks are known, misclassification often happens at the execution level. In pharma, the urgency to scale project-based teams can lead to shortcuts.
Hiring managers may push for speed, while central HR or procurement teams default to global templates or past practices, classifying roles as contractors without taking the time to verify whether they meet local legal criteria. Without proper legal review or local oversight, these decisions can easily result in misclassification and regulatory exposure.
Instead of achieving the shorter timelines they want, they can end up derailing the entire process.
Using EoR and AOR models to reduce risk and increase speed
One way pharma leaders can manage classification risk is by using Employer of Record (EoR) and Agent of Record (AOR) solutions—both offered by CXC. These models enable companies to engage talent across EMEA without establishing local entities, while ensuring all contracts, tax obligations, and employment requirements are fully compliant.
For example, a UK-based pharma firm looking to test a rare disease therapy in the Czech Republic can hire clinical staff through an EoR provider. This ensures full local compliance while retaining operational control, without the need to wait six months to set up a Czech subsidiary.
AORs, meanwhile, facilitate compliant engagement of independent contractors, ensuring accurate classification, contract terms, and payment flows. These solutions reduce internal burden while maintaining full visibility over risk.
Ensuring oversight and visibility across distributed teams
Even with proper classification, maintaining oversight of a global workforce is an ongoing challenge. Pharma companies need to know—at any given time—who is working where, under what terms, and whether those terms are compliant with regulations. However, with teams spread across various clinical sites, remote setups, and cross-border projects, critical details can easily slip through the cracks.
Fragmented systems make it hard to manage workforce data at scale, especially when tracking contract terms, benefits, and local entitlements. Without a central platform, HR and legal teams stay stuck in reactive mode, increasing the risk of non-compliance.
Centralising compliance and reporting
CXC Comply is a solution designed to help companies ensure and manage compliance at scale. Designed for multi-country use, it provides real-time dashboards that track key compliance markers, including worker classification, right-to-work verification, and background vetting. This central visibility makes it easier to stay audit-ready, maintain accurate records, and support regional decision-makers.
The result? Leadership teams gain confidence, audits become less disruptive, and cross-functional alignment improves—without relying on dozens of disconnected spreadsheets or datasheets on different platforms.
Empowering teams with compliance tech
Digital compliance platforms today do more than track data—they help teams act on it. Automation features can now trigger alerts for expiring contracts, flag working-hour violations, and guide HR through localised onboarding steps using country-specific templates.
For example, when hiring in France, tools like CXC Comply can automatically generate compliant permanent contracts—known as Contrats à Durée Indéterminée (CDIs)—and notify HR if thresholds, such as the 35-hour workweek, are exceeded under the French Labour Code.
This turns compliance from a reactive task into a proactive advantage, freeing up HR and legal teams to focus on strategic priorities instead of firefighting avoidable issues.
Data privacy and digital health innovation in global pharma
As pharma companies adopt more tech-enabled models (remote teams, digital trials, and AI-powered research), the scope of compliance continues to shift.
It’s no longer just about contracts and classification. Sensitive patient data now moves across systems, borders, and third-party platforms at a rapid pace, often under the watchful eye of frameworks like the GDPR.
This is especially true with the rise of digital health innovation. Tools such as wearable devices, mobile applications, and remote diagnostics rely on the collection of real-time health data. While helpful, they also raise new risks around consent, cross-border transfers, and third-party data handling.
Navigating GDPR and clinical data requirements
Europe’s flagship privacy law sets a high bar for clinical data handling as it also covers consent, minimisation, and storage limits. But each country applies it differently.
- Spain treats health data as specially protected, requiring extra safeguards and, in some cases, prior approval from its data protection authority.
- Ireland imposes strict controls on transferring clinical data to countries outside the European Economic Area (EEA). So, even under one EU framework, a digital trial across both markets may require distinct governance protocols.
Digital health and new regulatory frontiers
While GDPR dominates much of the data privacy discussion, it’s not the only frontier. As pharma expands into digital therapeutics, regulators are introducing entirely new frameworks to govern emerging technologies.
- For instance, in the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) now requires that Software as a Medical Device (SaMD)—like digital asthma monitors or AI-powered diagnostics—meet specific clinical validation and cybersecurity standards.
- Meanwhile, countries like the UAE are formalising digital health regulations under new frameworks, such as Federal Decree-Law No. 45 of 2021, which sets rules on health data processing, hosting, and cross-border transfer.
These evolving rules shape everything from product design to market access. To stay ahead, pharmaceutical teams must integrate regulatory planning into R&D and ensure that digital tools meet not only clinical standards but also legal ones.
Partnering smart: CXC as a compliance and growth enabler
Tackling all of these challenges—local onboarding, worker classification, data handling, compliance tracking—requires a level of specialisation that many internal teams can’t manage alone.
That’s where a global compliance partner like CXC becomes invaluable.
Infrastructure for agile growth
CXC’s EoR, AOR, and Comply solutions provide the operational backbone pharma companies need to expand quickly and compliantly. With coverage in over 100 countries and decades of experience, CXC delivers local expertise, contract compliance, payroll, tax submission, and real-time reporting—removing the need to set up local entities.
Need to launch a trial in Hungary within weeks? Or onboard a regulatory affairs consultant in South Africa without a legal presence? CXC handles the compliance heavy lifting—so your team can stay focused on science and delivery.
Freeing up internal teams for innovation
The greatest value of a compliance partner like CXC isn’t just risk reduction—it’s bandwidth. Instead of stretching HR and legal across localisation, classification, and tracking updates across dozens of markets, those teams get the space to focus on strategic priorities. In pharma, where precision and speed define success, that reclaimed capacity isn’t a nice-to-have—it’s a competitive edge.
A roadmap to compliant global scale
Expanding pharma operations across EMEA is no longer just about growth—it’s about doing it right. In today’s environment, compliance can’t be an afterthought. It needs to be built into every hiring plan, every clinical rollout, and every cross-border partnership from the start.
By combining regulatory foresight, structured frameworks, and the right technology, companies can transform compliance into a competitive advantage, rather than a barrier. That’s where working with a trusted partner like CXC makes a difference. With deep regional expertise and purpose-built solutions, we help pharma companies scale faster, safer, and with full confidence in their compliance.
Talk to us today to see how we can support your next phase of global growth.
