Our latest News & Events
The Quality Charter for Promotional Practices: A New Framework for the Promotion of Health Products
In March 2022, the Quality Charter for Professional Practices was published to provide a framework for the presentation, information and promotion of medical devices for
What substitution for hybrid Medicines in France? Status of the ANSM Hybrid Groups Register
A laborious creation of the register of hybrid groups The purpose of the hybrid group registry is to enable substitution in certain medical situations, taking
What are the differences between the Mutual Recognition Procedure and the Decentralized Procedure ?
From a legislative point of view, the mutual recognition procedure is defined by the Directive 2001/83/EC of the European Parliament and of the Council of
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,
The French Repository for Generic medicinal Products
What’s the French Repository of Generic Medicinal products ? According to European regulation, ‘Generic medicinal product’ shall mean a medicinal product which has the same
What is an EU RMP ?
A Risk Management Plan (RMP) is an essential element of pharmacovigilance activities. Its primary objective is to identify, characterize, and minimize the risks associated with
ICH and its influence on global regulation
Presentation of ICH (roles, history, missions, etc.) ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) is an organisation that brings together
Paediatric Investigation Plans & paediatric requirements in the EU
The need for a paediatric regulation for medicines The need for a paediatric regulation in the EU is born almost 30 years ago with the
Atessia takes a strategic leap with the integration of AnticipSanté
This merger enriches our service offering and affirms our commitment to supporting healthcare players in meeting the regulatory and operational challenges of today and tomorrow.