NIS 2 Expertise: Anticipate. Secure. Comply with RealDev
Turn regulatory compliance into a strategic advantage for your pharmaceutical company or automated production environment.
NIS 2: The European Directive Redefining Industrial Cybersecurity
The European NIS 2 directive requires companies in strategic sectors to strengthen their cybersecurity to protect critical infrastructures and ensure the resilience of essential services.
In an increasingly interconnected industrial environment, where automated production systems (SCADA, PLC, MES…) are at the core of operations, compliance with NIS 2 has become an unavoidable challenge.
👉 At RealDev, we help our clients turn this obligation into an operational advantage: enhanced security, reliability, and performance.
RealDev, a trusted partner for NIS 2 compliance
Deep expertise in the pharmaceutical sector
For several years, we have supported leading pharmaceutical laboratories in securing their critical environments:
- SCADA systems & automated production lines
- Computer system validation (CSV)
- Data integrity governance (ALCOA+, GAMP 5)
- FDA 21 CFR Part 11 compliance
This experience enables us to balance NIS 2 requirements, GxP constraints, and industrial performance.
Expertise in complex industrial infrastructures
We operate in highly technical environments, often hybrid between IT and OT:
- Industrial controllers (PLC), supervision (SCADA), and management (MES)
- Industrial networks (OT/IT)
- Production IoT & smart sensors
- Interconnected critical systems
Our approach is cyber-industrial: we secure your systems without compromising the performance of your production lines.
A complete NIS 2 offering, from audit to full compliance
Audit & Maturity Assessment NIS 2
We conduct a comprehensive diagnosis of your cybersecurity posture, industrial processes, and IT/OT infrastructures to assess your exposure to NIS 2 requirements.
Tailor-made action plan
We work with your teams to build a clear, realistic, and prioritized compliance roadmap, taking into account your operational, regulatory (GxP, ISO), and budgetary constraints.
Integration of technological solutions
Leveraging our expertise in Digital Solutions and Process Control, we implement cybersecurity tools (SIEM, EDR, MFA, etc.) tailored to your critical operations—without slowing down your productivity.
Governance & awareness
Defining roles and responsibilities, incident management procedures, and integrating cybersecurity into your company culture — we help you build a strong and effective governance framework.
Documentation & proof of compliance
We support you in creating key documents (incident response plan, security policy, registers) to ensure your compliance with regulatory bodies (CSIRT, ENISA).
Sectors affected by the NIS 2 Directive
The directive targets “essential” or “important” entities in critical sectors. You are affected if you are:
- 💊 A pharmaceutical manufacturer
- ⚙️ An automated factory (metallurgy, agri-food, chemical industry…)
- 🧬 A producer or provider of critical technology services
- 🌍 A company with more than 50 employees or over €10M in revenue
The essential to remember
NIS 2 replaces and strengthens the original NIS directive by expanding its scope and tightening its requirements. It mandates that essential and important entities must:
- Implement appropriate cyber risk management measures
- Establish clear governance for information system security
- Ensure detection, prevention, and response to cyber incidents
- Apply controls to guarantee operational continuity
- Raise awareness and train employees on cybersecurity issues
For Life Sciences companies—where quality, regulatory compliance, and data security are critical—NIS 2 is both a strategic and regulatory imperative.
Take action now
Don’t wait
The NIS 2 compliance deadline is fast approaching. Companies that anticipate and prepare will gain a significant strategic advantage—while avoiding the risk of penalties.
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Quick FAQ on NIS 2
What is NIS 2?
NIS 2 is a strengthened European directive imposing strict cybersecurity obligations on key economic sectors, including critical infrastructures and providers of essential services. It replaces and significantly broadens the scope of the original NIS directive.
When does it apply?
The directive came into effect on October 17, 2024. However, achieving compliance requires several months of preparation—including risk analysis, documentation, awareness training, and technical security measures. It is therefore crucial to act now to anticipate regulatory inspections and avoid penalties.
My company is already GxP compliant. Is that enough?
No. GxP compliance (or FDA 21 CFR Part 11) does not cover all the requirements of NIS 2. NIS 2 imposes additional obligations related to organizational cybersecurity, cyber risk governance, incident notification, and executive accountability.
What are the risks of non-compliance?
Sanctions can reach up to €10 million or 2% of global annual turnover. Beyond fines, management can be held personally liable. Unmanaged incidents can also lead to loss of trust from customers and partners.
Can RealDev help me even if I have already started my compliance journey?
Yes. We work both upstream (audit, roadmap) and as reinforcement to finalize critical aspects, review your documentation, test your systems, or raise awareness among your teams. We tailor our support to your level of maturity.
Let’s talk about your compliance
Do you want to anticipate the NIS 2 directive and strengthen your cyber resilience without disrupting your operations?
Contact us for an audit, action plan, or personalized support.