Life sciences global industrial and quality consulting 'Project Management, Operations, Quality Compliance and Audits'. Standards and regulations: EU Vol. 4, EU GMP/GDP, 21 CFR part 210/211/820, ICH Q7/Q9, IPEC Excipient GMPs/GDP, ISO13485, ISO 22716, ISO 17025, ISO 22000, HACCP, ISO 9001, Drug Nitrosamines risk analyzes etc. Varied experiences in the following companies: Lonza Cell & Gene Therapy Netherlands - Merial France - Sanofi Pasteur France - Octapharma France - Assistance Publique Hôpitaux de Paris France - SQA Services US (Pfizer - Merck - Baxter) - SpineSave AG Switzerland - Blanco Medical Germany - Swiss Medtech Switzerland - Laboratoires Sicobel France - Martin Dow Pharmaceuticals France - Innothera France - VEEVA Systems Vault. In various specialties: Cell and Gene Therapy - Human and Veterinary Vaccines - Human Blood - Rares Diseases - Generic Drug - Spine Implant - Medical Furniture - Dermocosmetics - CSV Computer System Validation. We have a series of services including: - Quality Assurance Operations & Systems, Compliance - Quality Project Management - Pharma, CDMO and Biologics Technology Transfer - Suppliers and Subcontractors Qualification and Management - Internal and External Audits, EU and FDA Inspections Readiness - GxP Computerized System Validation - Good Distribution Practices (GDP) - French headquarters Quality Assurance "QA Exploitant"