We provide consistent support from the formulation of regulatory response strategies for pharmaceuticals to the preparation, review, and submission of necessary documents!
When a company expands overseas, it is necessary to be well-versed in the local laws to comply with local regulatory requirements and avoid regulatory violations and delays in approvals. Experienced regulatory compliance consultants with practical experience in the pharmaceutical and medical device industries provide support services tailored to your needs, ensuring that related documents comply with stringent regulations. [Pharmaceutical Sector] We support product registration in the EU, China, the United States, and Latin America, monitor and track progress, and communicate with regulatory authorities on behalf of our clients. [Medical Device Sector] We prepare registration documents and technical materials for MD and IVD products.
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basic information
【Pharmaceutical Field Support】 ◆ Regulatory Affairs and Strategic Development - Regulatory strategy master plan and feasibility study (strategic support on a global scale) - Review of bioequivalence study design - Overall development planning - Clinical trial support ◆ Regulatory Support for Marketing Authorization - Full support for drug registration applications - Lifecycle management of pharmaceuticals (change management with regulatory authorities) - Preparation of various documents and electronic submissions 【Medical Device Support】 ◆ MD Regulatory Services - U.S. agent - 510K - Device listing - Manufacturing facility registration - Regulatory intelligence - Regulatory compliance strategy planning - Preparation and evaluation of technical documents
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Applications/Examples of results
Regarding regulatory-related business services, the PQE Group has supported approximately 400 companies and 1,200 projects over the past 10 years.
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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.