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ATESSIA, Your Guide to Efficient Regulatory Affairs in the Pharma Industry
In the intricate and highly regulated world of pharmaceuticals and healthcare, ATESSIA stands out as a consulting firm dedicated to guiding companies through the complexities
ATESSIA Named Among the “5 Best Pharma Consulting Companies to Watch in 2024”
We are proud to be featured in The Silicon Review, a recognition that highlights our unwavering commitment to excellence in regulatory affairs. In the pharmaceutical
Forbes – ATESSIA, Life Science Advisors : The Regulatory and Pharmaceutical Affairs Consulting Firm Dedicated to the Healthcare Industry
Leveraging its expertise, ATESSIA supports a wide range of health products, with a particular focus on pharmaceuticals and medical devices. Through a tailored and rigorous
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