Philippe Bollen

Industrial Pharmacist with extensive experience across pharmaceutical manufacturing, medical devices, and clinical trial operations, combining Quality Management, Regulatory Affairs, and Business Operations at an international level.
Over a career spanning more than 20 years, he has led and implemented Quality Management Systems (QMS) covering purchase, reception, testing, release, and distribution of medicinal products. His expertise includes GMP, GDP, ISO 13485, CE marking (Dir 93/42/EEC), and compliance with major health authorities such as AFMPS, MHRA, WHO, SGS, and corporate inspection bodies.
He has managed change control, CAPA systems, quality agreements, and CMO oversight, while supporting organizations before, during, and after inspections. His regulatory background includes marketing authorization submissions, variations, clinical trial applications, and CE certification of medical devices.
With strong international exposure (Europe, India, Pakistan, China, USA), he has supervised contract manufacturers, packaging vendors, and clinical trial supply chains, ensuring GMP compliance, operational performance, and budget control. His profile reflects a rare combination of technical depth, regulatory intelligence, and operational pragmatism.