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

Implementing the new EU Legislation on advanced therapy Medicinal product

Informa UK Ltd

An EMA workshop in london gave an important insight into the implementation of the European regulation on Advanced Theraphy Medicinal Products (ATMPs).

Building an affordable innovative drug development chain

Express India

Every time there is a new regulation requested by the government, or generated by the industry needs, our scientific and technical contributions not only help us to remain updated but also aware of the philosophy underlying new regulations. Dr Emmanuelle Voisin, CEO, Voisin Consulting spoke on the trends in regulation and how India fits into her plans to build an affordable innovative chain, from discovery to market.

European Biotech sector struggles to survive funding crisis, Monthly, June 2009

The Center Watch

One in five European small biopharmaceutical companies faces the rick of bankruptcy by the end of 2009. the situation could worsen if the economic downturn continues into 2010, warns the European Biopharmaceutical Enterprise (EBE).

Chapter RAPS: Working as an Independent Consultant in Regulatory Affairs

RAPS Career Book

The European Regulations for Orphan Medicinal Products have been successfully implemented in the EU. Many companies have used or are using these regulations as is demonstrated by the high number of applications to the COMP. Only a limited number of products with Orphan Medicinal Product Designation have reached the market.

Update on the implementation of the European ATMP regulation


A July 2009 adoption/publication of a revised Annex I of Directive 2001/83/EC is foreseen. Discussions on how to appropriately assess combined ATMPs are advanced, with the CAT medical device experts directly involved in these discussions.

Personalized Medicine: From Concept to Reality, Nov edition

Fierce Biotech

As major pharma companies position themselves to market drugs in years to come, they’re seeing fewer blockbuster therapies on the horizon. The future lies in following the development model used by biotech companies to advance new medicines designed to target smaller populations with much more effective therapies.