Center of Life Sciences Excellence & Trust
Comprehensive life sciences solutions built on trust, expertise, and proven results
Building lasting relationships through transparent communication, reliable delivery, and ethical practices. Trust is the foundation of successful life sciences partnerships and regulatory compliance.
Comprehensive QA management for GxP-regulated environments, ensuring adherence to FDA, CE, GDPR, and HIPAA standards across all product lifecycle stages.
Cutting-edge AI ISO 42001 certification expertise, implementing intelligent automation solutions for eQMS, ALM, and ISMS to drive operational efficiency.
Advanced security frameworks including ISO 27001, ISO 27017, and comprehensive risk assessment strategies (ISO 14971) for life sciences organizations.
Expert Computer System Validation (CSV) according to GAMP5 and V&V methodologies for pharmaceutical and biotech systems. Comprehensive compliance with ISO 9001, ISO 13485, 21 CFR Part 820, and 21 CFR Part 11/Annex 11 requirements.
Strategic regulatory planning, audit preparation, and compliance integration for medical devices (ISO 13485), pharmaceuticals, and emerging life sciences technologies.
In life sciences, trust isn't just a value — it's the foundation of everything we do. From regulatory compliance to patient safety, trust drives quality, integrity, and success.
Consistent delivery of quality results with unwavering commitment to excellence
Ethical practices and transparent communication in all our professional relationships
20+ years of proven experience in life sciences quality and compliance leadership
Commitment to the highest standards of quality and regulatory compliance
With over 20 years of progressive experience in quality assurance and compliance leadership, I build trusted partnerships with organizations by delivering reliable, transparent, and ethical consulting services across leading companies including IBM, Johnson & Johnson (Omrix Biotechnology), and Teva Pharmaceuticals.
My approach is founded on trust - understanding that successful regulatory compliance and quality management require not just technical expertise, but also reliable partnerships and transparent communication with clients, regulatory bodies, and stakeholders.
I combine business acumen with deep technical expertise in life sciences, focusing on building long-term relationships that drive sustainable quality improvements and regulatory success.
Raanana, Israel
Trust-based partnerships