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…
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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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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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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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PNR are delighted to announce the MHRA approval of our new facility in Blaenau Gwent, South Wales. We hold MIA, MIA(IMP), MS and WDA licences which allow us to expand…
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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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We are delighted to welcome Tony Pinney to PNR Pharma as Qualified Person. Tony has over 30 years’ experience within the Pharmaceutical Industry with various roles within Quality. After qualifying as a QP…
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