PQE Japan Product Lineup

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.

• Other Consulting Services

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.

• Manufacturing Facility

Data integrity (DI) is an extremely important factor for companies in the life sciences sector, such as pharmaceuticals and medical devices, in both regulatory and business contexts. PQE supports the achievement of your compliance with an integrated data governance system that ensures the quality system functions effectively. To conduct DI related to regulations, computer system validation is crucial, and as a global leader in this field, we provide excellent support to our clients from both cost and practical perspectives.

• Other Consulting Services