PQE covers a wide geographical area and supports timely and efficient audit implementation! Remote audits are also available.
Introduction to Third-Party Audits - 5-Minute Video Recent regulations related to pharmaceutical development, starting materials and suppliers, regulations concerning medical devices, supplier qualification assessments, and audits have become more important than ever from a GxP perspective. Furthermore, both the EU and FDA strongly recommend third-party audits. PQE, with over 15 years of experience in the life sciences field, conducts various audits globally for pharmaceutical and medical device manufacturers. PQE has a qualification assessment process for auditors and a matrix of methods adopted by many of the world's top 50 companies, and it has obtained ISO certification as a quality system.
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basic information
【Pharmaceutical Sector】 Manufacturers of APIs, excipients, and intermediates CMO sales agents and logistics providers for FDF biosimilar manufacturers (labs/GMP/GLP) CROs Due diligence audits of GxP compliance IT systems and business plans Software suppliers Clinical and preclinical audits Clinical trial site audits Sterilization facilities Suppliers of equipment and utilities Pharmacovigilance and safety issues 【Medical Device Sector】 Mold suppliers Process equipment and utility suppliers Raw material manufacturers Parts and semi-finished product manufacturers OEM manufacturers Contract manufacturing organizations Contract testing organizations Sterilization facilities Distributors and logistics providers Software application suppliers (PDA and Tick-it certified auditors) Clinical trial centers Due diligence (quality) regarding product and facility acquisition
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Delivery Time
※It varies depending on the location and requirements. Please feel free to contact us.
Applications/Examples of results
- Deployment of auditors in each country - Over 100 audit achievements per month for customers worldwide - Conducting diverse audits such as API, final products, and packages - Virtual audits and remote audits are also possible
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Company information
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.
