VCLS authors a number of articles on key industry journals, such as TOPRA Regulatory Rapporteur, Regulatory Focus from RAPS.
Latest Publications
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Clinical Trials in the EU/EEA: focus on CMC aspects
Clinical Trials in the EU/EEA- Focus on CMC Aspects Clinical trials testing the Benefit/Risk ratio of Investigational Medicinal Products (IMPs)…
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Current Clinical Trial Scenario of India
The Indian Clinical Trial Industry, considered as the booming sector and perceived as a potentially upcoming segment, is undergoing turmoil…
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The Proposed EU IVD Regulation and its Impact on Companion Diagnostic Development
Stricter rules are in store for CDx stakeholders in the EU but it’s not all bad news. Sylvie Le Glédic,…
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Designing a CMC Strategy For Advanced Therapy Medicinal Products (ATMP) in EU
Valerie Pimpaneau and Anne Dupraz Poiseau discuss the latest EU guidelines on ATMPs and explain how to develop a solid…
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Development of orphan products and the impact of the EU Paediatric Regulation, TOPRA Vol 9,…
Development of orphan medicinal products (OMPs) is challenging by nature: knowledge is usually limited; the patient population are small and…
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Quality by Design: a beginner’s guide
Quality by design (QbD) is becoming increasingly utilized as a valuable tool for focused and efficient drug development. Centering on…
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Nutraceuticals and functional food regulations in key emerging markets
Nutritionals & Nutraceuticals describe the group of products occupying the grey zone between food and medicines and having recognisable health…
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Applying for Multinational EU Trials Can be Faster via Voluntary Harmonisation Procedure (VHP)
Using the voluntary harmonisation procedure to apply for permission to conduct multinational clinical trials across the EU can, in some…
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