Pharmaceuticals
Pharma compliance. Automated.
Pharmaceutical companies operate under some of the most demanding regulatory requirements in Europe. NIS2 classifies healthcare and pharma as essential infrastructure. GDPR governs clinical trial data and patient information. The EU AI Act regulates AI-driven drug discovery and diagnostics. ISO 27001 underpins information security for IP-sensitive research data. Matproof automates compliance across all of these frameworks.
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Key Compliance Challenges in Pharmaceuticals
Pharmaceutical manufacturers, research organizations, and medical device companies are classified as essential entities under NIS2. This means mandatory risk management, 24-hour incident reporting, supply chain security for manufacturing and distribution systems, and personal liability for management bodies.
Clinical trial data involves special category personal data under GDPR Article 9. Processing requires explicit consent or specific legal bases, with strict requirements for pseudonymization, cross-border transfers to trial sites, and data subject rights that must be balanced against scientific research exemptions.
Pharmaceutical companies increasingly use AI for drug target identification, molecular design, clinical trial optimization, and pharmacovigilance. The EU AI Act imposes requirements on high-risk AI systems in healthcare, including data governance, human oversight, and transparency obligations that R&D teams must now address.
Pharmaceutical R&D data, proprietary formulations, and clinical trial results represent billions in intellectual property. ISO 27001 certification is increasingly required by partners and regulators, but implementing an ISMS across global R&D operations, manufacturing sites, and CRO partnerships is complex.
Frameworks That Apply to Pharmaceuticals
Pharma companies face a unique regulatory intersection of cybersecurity, data protection, AI governance, and information security.
Essential entity status for pharma manufacturers and healthcare organizations. Full risk management, incident reporting, and supply chain security requirements.
Clinical trial data protection, patient information governance, cross-border data transfers, and special category data processing requirements.
High-risk AI classification for healthcare AI systems. Data governance, human oversight, transparency, and conformity assessment requirements for AI in drug discovery and diagnostics.
Information security management for R&D data, clinical trial systems, manufacturing operations, and CRO partner ecosystems.
How Matproof Helps Pharmaceutical Companies
Compliance automation built for the regulatory complexity of pharmaceutical operations.
Map manufacturing, R&D, and distribution systems against NIS2 requirements. Matproof automates risk assessments, incident classification and reporting, and supply chain security documentation for your entire pharmaceutical value chain.
Automate GDPR compliance for clinical trial data - lawful basis documentation, DPIA workflows, cross-border transfer mechanisms, and data subject rights management. Purpose-built for the complexity of multi-site, multi-country clinical programs.
Document and manage AI systems used in drug discovery, clinical decisions, and pharmacovigilance. Matproof tracks risk classifications, data governance measures, human oversight protocols, and generates the technical documentation the EU AI Act requires.
Implement ISO 27001 controls across R&D operations, CRO partnerships, and manufacturing sites. Matproof automates evidence collection from lab systems, document management platforms, and access control infrastructure.
Pharma Compliance in Numbers
NIS2 initial incident notification deadline
GDPR breach notification deadline
reduction in manual compliance work
average time to first framework audit-ready
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