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

Overview of the EU CTA Regulatory Framework and Future Direction of the EU Clinical Trial directive

Pharma Bio World

Over the last few years, the European authorities have undertaken substantial new regulatory initiatives regarding the conduct of drug development activities, Clinical Trial Application (CTA) and Marketing Authorisation Application (MAA) submissions.

IIR's Partnership Debuts in the Asia Pacific

Applied Clinical trials

Representing more than a third of the world’s population, the Asia-Pacific is an attractive option for cost-effective clinical research regardless of whether the target market for the product is within or outside the region. However, if the clinical research is not conducted efficiently, or to an appropriate level of quality, the anticipated savings can in fact lead to costly mistakes.

Working as Independent Consultant

RAPS Book Chapter

An Independent Consultant is broadly defined as a person who is self-employed and works for clients in a specific field on a per-project basis. In this article, we provide a description of the general roles of a Regulatory Affairs Independent Consultant.

Defining a PIP strategy for a new medicinal product: A step by step approach,TOPRA Vol 6, No.5

Regulatory Rapporteur

A key step in the preparation of a paediatric investigation plan (PIP) for a new medicinal product is to define the PIP strategy, ie, to define how the studies/data extrapolation/waiver/deferral combination will cover, for each targeted indication, all subsets of the paediatric population.

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.