Haltys Pm 'pharma & Medtech'

HALTYS is a Global Consultancy specializing in Quality, Audit, and Compliance within the Life Sciences sector. Our consultants leverage extensive experience, delivering robust technical expertise complemented by a tailored facilitation approach to meet the specific objectives of our partners. 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 HACCP, ISO 9001, Drug Nitrosamines risk analyzes etc. References: Lonza Cell & Gene Therapy Netherlands for Kite Pharma - 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 - IPSEN BIOPHARMA Speciality Care - BLUEPRINT MEDICINES US - FDA QRC US. Sectors References: Cell and Gene Therapy CAR-T Cells - Human and Veterinary Vaccines - Human Blood Enzymes - Rares Diseases - Speciality Drug - Generic Drug - Spine Implant - Medical Furniture - Dermocosmetics - CSV Computer System Validation. What are the core intervention topics we specialize in- Quality Assurance Systems, Operations, and Regulatory Compliance - Internal and External Audits, EU and FDA Inspections Readiness - Comprehensive Risk Assessment Across All Levels - Project Management and Facilitation: Orchestrating Success - Qualification and Management of Raw Materials, Suppliers, and CDMOs (Contract Development and Manufacturing Organizations)- Deviation, Change Control, Complaint, Corrective and Preventive Actions (CAPA), and Key Performance Indicators (KPIs)- Pharmaceutical Technology Transfer - Computer System Validation (CSV)- Medical Device ISO 13485 - Global Quality Commercial Operations : Creation, Support, Supervision and Management of Affiliates at Global Headquarter.