PVCON Consulting Services is a “One Stop Shop" for all PV needs for its clients; it was founded by the globally recognised and well respected PV expert, Moin Don, with its headquarters based in Mumbai, India. For over five years, PVCON has been actively involved in a wide range of PV related services, and is a niche service provider, offering specialist expert support and consultancy in matters relating to all types of Good Pharmacovigilance Practice (GVP) Quality Assurance auditing and risk-based audit program development (e.g. Affiliate / Local Operating Company, PV Systems, Marketing Partners, and Service Providers/Vendors). PVCON provides consultancy in PV Quality Management Systems (QMS) development, maintenance & management, as well as all types of PV operational activities, systems, processes. PVCON also offers QA auditing support in Good Clinical Practice (GCP), Good Distribution Practice (GDP), and Computer System Validation (CSV). PVCON has helped setting up PV department/function for some of the well known national & international pharmaceutical companies & CROs. PVCON is acknowledged and recognised by its large client portfolio, ranging from small biotech, generics, to large global pharmaceutical companies, including Regulatory Authorities across South East Asia, Commonwealth of Independent States (CIS) and EMEA. PVCON collectively offers approximately 50 (man years) of experience in working within the pharmaceutical and regulatory authority environment (clinical, manufacturing, distribution and post-marketing safety surveillance). Highlights: • Complete PV Solutions • Audits, Quality Assurance & Inspection Readiness • End to End Case Processing • Aggregate Report • EU Qualified Person • ICSR Review & Narrative Writing • Literature Search activities • PMS Studies • SOP & WI Development • Software installation, Validation & Roll out • Recruitment & Training on PV domain & client processes