PQE Japan
PQE Japan Company Profile
Comprehensive consulting for pharmaceuticals and medical devices (GxP compliance, audits, CSV, DI, etc.)
PQE Group was established in Italy in 1998 and celebrated its 25th anniversary last year. It is a consulting company certified with ISO9001, providing a variety of consulting services in the life sciences industry for pharmaceutical companies, medical device companies, and manufacturers. As part of GXP system support, it offers services such as CSV, digital governance, and DX compliance, as well as data integrity assessments and accompanying improvement support. Additionally, it provides inspection response solutions for FDA, EMA, and others, and has extensive knowledge of the latest regulatory information from various countries, enabling support for overseas approval applications, eCTD creation and management, matching with overseas manufacturers of target active pharmaceutical ingredients, master file creation and management, gap analysis and strategy development support, and pre-approval market research, along with CQV services such as equipment and instrument qualification assessments. For third-party audits of GMP, GDP, GCP, and GVP, it is capable of conducting audits on a global scale. With a wide portfolio, extensive experience in each service, effective project management, and excellent cost-effectiveness, it has a strong track record of supporting a range of clients from global corporations to Japanese companies and venture firms.
Business Activities
【Services】 ■ Data Integrity (DI) ■ Commissioning & Qualification ■ Quality Engineering ■ Digital Governance ■ Laboratory Excellence ■ Quality Compliance ■ Regulatory Affairs ■ Auditing ■ Training
Products/Services (3)
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Detailed information
| Company name | PQE Japan |
|---|---|
| Contact address | postalcode 545-6031 Osaka/ Abeno-ku, Osaka-shi/ Abeno Harukas, 31st floor, Room 3105, 1-1-43 Abeno-sujiView on map TEL：06-6625-5093 FAX：06-7732-3757 |
| Key Partners | Pharmaceutical companies, medical device manufacturers, food and cosmetics companies, etc. |
| Industry | others |
PQE Japan Building Image