Distribution in the pharmaceutical industry is far more complex than many other sectors, given the sensitive nature of the products involved. Pharmaceutical companies must manage regulatory compliance, ensure product…
Learn MoreInvestigational 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…
Learn MoreThe 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…
Learn MoreSecondary 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…
Learn MoreInvestigational 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…
Learn MoreWhat 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…
Learn MoreQualified 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…
Learn MoreWhen 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…
Learn MoreAs 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…
Learn MoreIn 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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