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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Overview of the EU CTA Regulatory Framework and Future Direction of the EU Clinical Trial…
Over the last few years, the European authorities have undertaken substantial new regulatory initiatives regarding the conduct of drug development…
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IIR’s Partnership Debuts in the Asia Pacific
Representing more than a third of the world’s population, the Asia-Pacific is an attractive option for cost-effective clinical research regardless…
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Working As An Independent Consultant
An Independent Consultant is broadly defined as a person who is self-employed and works for clients in a specific field…
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Defining a PIP Strategy for a New Medicinal Product: A step by step approach
A key step in the preparation of a paediatric investigation plan (PIP) for a new medicinal product is to define…
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Implementing the new EU Legislation on advanced therapy Medicinal product
An EMA workshop in London gave an important insight into the implementation of the European regulation on Advanced Therapy Medicinal…
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Building an Affordable Innovative Drug Development Chain
Every time there is a new regulation requested by the government, or generated by the industry needs, our scientific and…
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European Biotech Sector Struggles to Survive Funding Crisis
One in five European small biopharmaceutical companies faces the rick of bankruptcy by the end of 2009. the situation could…
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Chapter RAPS Working as an Independent Consultant in Regulatory Affairs
The European Regulations for Orphan Medicinal Products have been successfully implemented in the EU. Many companies have used or are…
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