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Understanding EUDAMED: The European Database on Medical Devices
The new regulation (EU) 2017/745 introduces new requirements to enhance the safety of patients and users. One of the novelties of this new regulation is
MDR Transition: New Responsibilities and Major Changes in the Medical Device Industry
Since 1994, medical devices have had to comply with the requirements of European Directives 93/42/EEC and 90/385/EEC. Conformity with this regulation allows the affixing of
Biological medicinal products substitution in France?
Biological medicinal products are used in the treatment of numerous pathologies, such as diabetes, cancer and autoimmune diseases. Any biological medicinal product whose patent has
How to open a pharmaceutical establishment in France?
In France, the Public Health Code (PHC) defines different status: Status Authorised activities Manufacturer Manufacture of medicinal products, products or objects referred to in Article
The Jardé Law and Research Involving Human Subjects (RIPH): How Are Pharmaceutical Companies Affected?
Medical research is essential for the development of new treatments and the improvement of healthcare. In France, this research is governed by strict regulations designed
The Excellence of ATESSIA’s CMC: Your Partner in Technical and Regulatory Affairs
In a constantly evolving pharmaceutical industrial environment, regulatory requirements for quality data are becoming increasingly complex. Health authorities are continually updating guidelines, increasing CMC demands
The Post-Approval Change Management Protocol or “PACMP”
In Europe, changes to a marketing authorisation (MA) for a human medicine are covered by Regulation (EC) No. 1234/2008 of November 24, 2008. This regulation
What are Good Manufacturing Practices (GMP) ?
Definition Good Manufacturing Practices are a set of principles and guidelines. The first GMPs were published in France in 1978. These guidelines are regularly updated
What are CEPs ?
CEP : what’s that? In Europe, three distinct possibilities exist for presenting information relating to the active substance, from a qualified manufacturer, used in a medicinal