Investigational Medicinal Products (IMPs) to be used in an EU clinical trial must be certified by a Qualified Person (QP) named on a Manufacturing and Import Authorisation (MIA(IMP)) to ensure…
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The MHRA introduced the QP Oversight process for clinical supplies entering into Great Britain from the EU/EEA after Brexit. The Medicines for Human Use (Clinical Trial) Regulations 2004 requires that…
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Secondary packaging and labelling of clinical trial material present unique challenges due to regulatory requirements, patient safety concerns, and logistical complexities. Navigating these challenges requires a comprehensive understanding of…
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Investigational Medicinal Products (IMPs) to be used in a UK clinical trial must be certified by a Qualified Person (QP) named on a Manufacturing and Import Authorisation (MIA(IMP)) to ensure…
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What is the UK QP oversight process for Investigational Medicinal Products? Sponsors of a UK clinical trial using IMPs imported into Great Britain from countries on an ‘approved country for…
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Qualified Person (QP) Declaration in Clinical Trials. When developing a new drug, it is critical to ensure that it is safe and effective for use in humans. Clinical trials are…
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When it comes to conducting clinical studies in EU and UK, one of the critical steps is obtaining Qualified Person (QP) certification. QPs play a crucial role in ensuring the…
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As the global pharmaceutical industry continues to expand, sourcing reliable and high-quality suppliers is crucial for ensuring the availability and integrity of medicinal products. China has emerged as a major…
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In recent years, the Chinese pharmaceutical industry has experienced remarkable growth and has become a significant player on the global stage. As the industry expands, meeting international standards and regulations…
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