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IMP Supply for EU Clinical Trials

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 QP Oversight Process

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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Challenges of Clinical Secondary Packaging and Labelling 

  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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IMP Supply for UK Clinical Trials

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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The UK QP oversight process for Investigational Medicinal Products

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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QP Declaration in Clinical Trials

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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Streamlining QP Certification for Clinical Studies in EU and UK

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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Expanding Your Supplier List: Considerations for Adding a Chinese Pharmaceutical Company

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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The Challenges of GMP Audits in Chinese Pharmaceutical Companies

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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EU GMP Annex 1: The Cost of Non-Compliance

The new GMP Annex 1 standards will enter into force on 25 August 2023 (except for Chapter 8.123, which is postponed until 25 August 2024), and all organisations involved in…

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