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Publications
We author publications presenting our opinions, methodological approaches to health
products development, and our views on environment changes.

Current Clinical Trial Scenario of India

2013
Pharma Bio World

The Indian Clinical Trial Industry, considered as the booming sector and perceived as a potentially upcoming segment, is undergoing turmoil today with a decline of 9.60 per cent in revenues, with further decline because of delay/decreased clinical trial approvals.

The proposed EU IVD Regulation and its impact on companion diagnostic development

2013
SCRIP Regulatory Affairs

Stricter rules are in store for CDx stakeholders in the EU but it’s not all bad news.

Designing a CMC strategy for advanced therapy medicinal products in EU

2012
SCRIP Regulatory Affairs

Valerie Pimpaneau and Anne Dupraz Poiseau discuss the latest EU guidelines on ATMPs and explain how to develop a solid chemistry, manufacturing and control strategy for such products.

Development of orphan products and the impact of the EU Paediatric Regulation ,TOPRA Vol 9, No.10

2012
Regulatory Rapporteur

Development of orphan medicinal products (OMPs) is challenging by nature: knowledge is usually limited; the patient population are small and often frail; and the implementation of the Paediatric Regulation in the EU has added a layer of complexity, especially for OMPs.

Quality by design: a beginner’s guide

2012
STP Pharma Pratiques

Quality by design (QbD) is becoming increasingly utilized as a valuable tool for focused and efficient drug development. Centering on case studies, we will look at how QbD can be used in its application to small molecules and biopharmaceuticals.

Nutraceuticals and functional food regulations in key emerging markets Part I ,TOPRA Vol 9, No.5

2012
Regulatory Rapporteur

Nutritionals & Nutraceuticals describe the group of products occupying the grey zone between food and medicines and having recognisable health and physiological benefits attributable to the efficacy of their consumption. In the more developed markets, these products have increasingly experienced more stringent regulatory controls for the primary reasons of product safety, public health and consumer protection.

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