Program Overview

The Aevum Zenth Health Sciences Compliance Program is designed to ensure that every subsidiary, research facility, manufacturing plant, and clinical operation adheres to the highest global standards. Our compliance infrastructure operates independently from business units to guarantee objectivity, transparency, and zero tolerance for regulatory deviations.

Key pillars include proactive risk assessment, continuous employee training, automated policy tracking, and direct reporting channels to our Global Compliance Office.

Regulatory Standards & Certifications

Our health operations are continuously aligned with and certified under the following regulatory frameworks:

FDA (USA)
Drug approvals, medical device clearance, cGMP, and clinical trial oversight.
EMA (EU)
European medicine authorization, pharmacovigilance, and GxP compliance.
ISO 13485
Quality management systems for medical device design, production, and distribution.
HIPAA / GDPR
Patient data privacy, secure health information exchange, and consent management.
ICH GCP / GLP
International Council for Harmonization standards for clinical and laboratory practices.
WHO Prequalification
Global health product standards for low- and middle-income market distribution.

Compliance Framework

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Policy & Procedure Management

Centralized repository of 400+ division-specific policies with automated version control, employee acknowledgment tracking, and quarterly review cycles.

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Risk Assessment & Monitoring

AI-driven compliance risk mapping across supply chains, clinical sites, and manufacturing hubs. Real-time dashboards flag deviations before they escalate.

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Mandatory Training & Certification

Role-based compliance training for 45,000+ health division employees. Includes GxP, ethics, data privacy, and anti-bribery modules with annual recertification.

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Third-Party Vendor Oversight

Strict due diligence, contract compliance clauses, and performance audits for all CROs, CMOs, distributors, and research partners.

Quality Assurance & Audit Programs

Quality and compliance are interlocked. Our internal audit team conducts scheduled and unannounced inspections across all health operations. Findings are tracked through our CAPA (Corrective and Preventive Action) system with documented resolution timelines.

  • Internal Audits: Biannual facility reviews, process validation, and documentation control checks.
  • External Audits: Third-party GMP/GCP certifications, regulatory agency inspections, and ISO recertifications.
  • Document Control: Electronic batch records, validated LIMS/ERP systems, and immutable audit trails.
  • Deviation Management: Root cause analysis, impact assessment, and preventative system updates.

Secure Reporting & Whistleblower Protection

Aevum Zenth maintains a zero-retaliation policy. If you observe potential regulatory violations, ethical breaches, or compliance failures, you are encouraged to report them immediately through our secure, anonymous channels.

Report a Compliance Concern

Submissions are encrypted, routed directly to the Global Compliance Office, and investigated within 48 hours. All reports are strictly confidential.

Hotline: +1 (800) 555-0199 | Email: compliance-report@aevumzenth.com | Available 24/7 in 14 languages

Health Sciences Compliance Office

For policy inquiries, training requests, or audit coordination, contact the dedicated compliance team for the Health Sciences division.

Global Compliance Director
Dr. Elena Rostova
Direct Line
+41 22 900 4082
Email
health.compliance@aevumzenth.com
Location
Zenth Tower, Floor 18, Neo Geneva