An independent Consultant, Executive Consultant PQE, Senior Consultant, Rephine Ltd UK (Engaged for EDQM compliance support, GMP auditing, gap analysis, Trainings on GDP, DI, Investigations & other GMP related topics to a multinational API manufacturing company in Gujarat)I am a Quality professional with 35 years of industrial experience on development, effective implementation & continual improvement of Quality Management Systems meeting Organizational & Regulatory expectations. Providing the consultancy services as an independent consultant also, mainly Training, Auditing & GMP / Regulatory gap assessment & compliance support.Recently provided the consulting services on EDQM / PMDA inspection support to a multinational API / KSM manufacturer in Ahmedabad. India. Hands on experience in handling various regulatory inspections like USFDA, EDQM, WHO GMP, PMDA, IMB, KFDA & other European audits without any quality concerns at the leading API manufacturing Organizations in the past as a senior most quality professional. An IRCA registered QMS Lead Auditor, certified by TUV Nord Germany, Conducted QMS/GMP audits hiNationally & Internationally.