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

Impact of the new pharmaceutical legislation on the development and registration of biological medicinal products in the EU ,TOPRA Vol 3, No.2

Regulatory Rapporteur

This article reviews the impact of the new pharmaceutical legislation on the development of biotech products. The authors describe in details current and new challenges that will have an impact on the development and preparation of the registration dossier of biologicals.

Human Tissues: Consultants call for end to EU regualtory confusion


Manufacturers of human tissue engineered products (hTEPs) need to develop a very strong position paper to put an end to regulators treating so many of these products as cell therapy products and compelling manufacturers to comply with the medicinal products Directive, 2003/63/EC.

Advanced therapies in the EU :speedy adoption or beleaguered by questions?


The industry is caught between wanting numerous questions answered on the text and a rapid implementation of new rules to end the current fragmented regulatory "nightmare" that currently exists in Europe.

The pros and cons of the Commission’s proposal for Advanced Therapy Products


The European Commission’s proposal for a Regulation on Advanced Therapy Medicinal Products (ATPs) is a significant step towards EU-wide harmonization, clarity and certainty for tissue engineered products. But the new clarity comes at a significant cost to the medical devices industry.

Regulatory Advanced Therapies in the EU: a square Peg in a round hole

Informa UK Ltd

Anne Dupraz Poiseau and Stuart Mudge examine the European Commission's proposal for a regulatory framework for human tissue engineered products.

Pathways and Strategies for combination products in the EU

The Regulatory Affairs Journal

Determining the regulatory path for a combination product is a difficult task. Even in the USA, which seems to have given the most consideration for and focus on defining and regulating combination products, it still involves much uncertainity.