𝗛𝗔𝗟𝗧𝗬𝗦 𝗜𝗦 𝗔 𝗚𝗟𝗢𝗕𝗔𝗟 𝗟𝗜𝗙𝗘 𝗦𝗖𝗜𝗘𝗡𝗖𝗘𝗦 𝗤𝗨𝗔𝗟𝗜𝗧𝗬, 𝗖𝗢𝗠𝗣𝗟𝗜𝗔𝗡𝗖𝗘 𝗔𝗡𝗗 𝗔𝗨𝗗𝗜𝗧 𝗖𝗢𝗡𝗦𝗨𝗟𝗧𝗔𝗡𝗖𝗬 𝗗𝗘𝗗𝗜𝗖𝗔𝗧𝗘𝗗 𝗧𝗢 𝗖𝗢𝗠𝗣𝗟𝗘𝗫 𝗣𝗥𝗢𝗝𝗘𝗖𝗧𝗦 𝗔𝗡𝗗 𝗦𝗧𝗥𝗔𝗧𝗘𝗚𝗜𝗖 𝗩𝗔𝗟𝗨𝗘 𝗖𝗥𝗘𝗔𝗧𝗜𝗢𝗡.

𝗦𝗧𝗔𝗡𝗗𝗔𝗥𝗗𝗦 𝗔𝗡𝗗 𝗥𝗘𝗚𝗨𝗟𝗔𝗧𝗜𝗢𝗡𝗦:
EU VOL. 4 · EU GMP/GDP · 21 CFR PARTS 210/211/820 · ICH Q7/Q9 · IPEC EXCIPIENT GMP/GDP · ISO 13485 · ISO 22716 · ISO 17025 · ISO 22000 · HACCP · ISO 9001.

𝗦𝗘𝗟𝗘𝗖𝗧𝗘𝗗 𝗖𝗟𝗜𝗘𝗡𝗧 𝗥𝗘𝗙𝗘𝗥𝗘𝗡𝗖𝗘𝗦:
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 GLOBAL · IPSEN BIOPHARMA SPECIALTY CARE GLOBAL · BLUEPRINT MEDICINES US · FDA QRC US · SEQENS FRANCE.

𝗢𝗨𝗥 𝗖𝗢𝗥𝗘 𝗔𝗥𝗘𝗔𝗦 𝗢𝗙 𝗜𝗡𝗧𝗘𝗥𝗩𝗘𝗡𝗧𝗜𝗢𝗡:
QUALITY ASSURANCE SYSTEMS, OPERATIONS, AND REGULATORY COMPLIANCE
INTERNAL AND EXTERNAL AUDITS, EU AND FDA INSPECTION 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)
DEVIATIONS, CHANGE CONTROL, COMPLAINTS, CORRECTIVE AND PREVENTIVE ACTIONS (CAPA), AND KEY PERFORMANCE INDICATORS (KPIS)
PHARMACEUTICAL TECHNOLOGY TRANSFER
COMPUTER SYSTEM VALIDATION (CSV)
MEDICAL DEVICES – ISO 13485
GLOBAL QUALITY COMMERCIAL OPERATIONS: CREATION, SUPPORT, SUPERVISION, AND MANAGEMENT OF AFFILIATES AT GLOBAL HEADQUARTER

HALTYS PM 'Pharma & Medtech'

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HALTYS PM 'Pharma & Medtech'

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