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The serialisation system
Securing the distribution of medicines represents an unprecedented challenge for public health. Although France has always benefited from a particularly secure drug distribution system and

The APQR review “à la française”
What is an APQR? Both US and EU Good Manufacturing Practices (GMP) require manufacturers of all authorized medicinal products to perform Annual Product Quality Reviews

The consulting profession at ATESSIA
In concrete terms, what does it mean to be a consultant in regulatory and pharmaceutical affairs at ATESSIA, Life science advisors? At ATESSIA, we firmly

Life Sciences Review: Atessia: Tailor-made solutions for Pharmaceutical Regulatory Changes 🇬🇧
We are happy to share that ATESSIA, Life Science Advisors was selected by Life Sciences Review among the top 10 regulatory consulting firms in Europe for 2022.

The mysterious thing that an Exploitant is
French always do it different In many domains, French people like to stand out, either in a positive or negative way. In the Healthcare field,

Registering gene therapy medicinal products
The regulatory requirements for the pharmaceutical development of gene therapy medicinal product are described in Annex I, part IV of Directive 2001/83/EC applied to advanced

How to manage a non-GMP raw material in your MA files?
French always do it different In many domains, French people like to stand out, either in a positive or negative way. In the Healthcare field,

How to proceed with non-pharmacopoeial excipients in the formulation of a medicinal product for human use?
French always do it different In many domains, French people like to stand out, either in a positive or negative way. In the Healthcare field,

Advertising for medicines: the keys to obtaining a visa in France
French always do it different In many domains, French people like to stand out, either in a positive or negative way. In the Healthcare field,