Atessia
Tailor-made Solutions for Pharmaceutical Regulatory Changes

Rapid digitalization, geopolitical crises, and constant regulatory changes have caused unpredictability in the pharmaceutical industry. Pharmaceutical consultancies entered the picture to help the pharma companies adapt to these changes, keep them up-to-date on technology, and ease compliance transition.

Atessia, Life science advisors, based in Paris, offers strategic pharmaceutical regulatory expertise and provides a full range of services for pharmaceutical or biotech companies planning to expand their operations into France. It also provides its clients with a tool known as Atessia Intelligence that allows professionals in the pharmaceutical field to stay up to date with the latest regulations applicable in the industry in order to stay competitive and proactive toward risks.

Atessia bridges the gap between the clients’ business challenges and technical solutions and bring clarity to complex challenges in the pharmaceutical industry. Its added value lies in a tailor-made approach providing the agility, adaptability, and ability to break industry conventions. That flexibility allows it to bear the client’s most complex challenges and to act as accelerators of the compliance process. Atessia’s Founder, Géraldine Baudot Visser, has developed a vision over 15 years of expertise in the field, which remains the company’s DNA and guideline. This vision focuses on offering an innovative thinking in this regulated environment and a valuable experience to all the company’s stakeholders which enabled Atessia to grow into a trusted advisor to small mid-size and large pharma and biotech organizations since 2017.

Along with helping its domestic clients, the firm assists foreign pharmaceutical companies in providing innovative treatments in France. Atessia provides their clients with a 360° support in all regulatory challenges to ease their way toward successful market access in Europe such as:
• Product registration in France

• Early and expanded access programs in France
• Establishing a subsidiary in France

Their complete and specialized portfolio of tailor-made solutions allows clients to rely on a trusted consulting firm with undeniable know-how in the field.

“Atessia supports foreign pharmaceutical companies in establishing their subsidiaries in France, assisting them to attain the regulatory status of ‘Exploitant’ and build quality management systems that work in parallel with their establishments,” states Géraldine Baudot-Visser, CEO of Atessia. ‘Exploitant’ status is essential for a company to start operations in France. In addition to the administrative process, the French authorities also need information such as quality, batch recalls, advertising, medical information, pharmacovigilance, and other relevant data about the product being placed in the market. The firm also helps companies understand the French market from a regulatory and pharmaceutical point of view.

When an American pharmaceutical company wanted to distribute a drug through the Early Access Program, Atessia assisted them in establishing a subsidiary in compliance with the rules and regulations. Additionally, it helped them achieve the ‘Exploitant’ status required for participating in the program. In collaboration with Atessia, the firm developed a quality management system that aligns with French regulations. The trusted relationship that Atessia built with this organization paved the way for it to collaborate with them on a new venture. This partnership was possible due to the expertise, rigorous analytic techniques, and quality of the customer-centric services it provides to clients.

Atessia implements the ISO-9001 standard in its Quality Management System to improve the quality of service and client experience offering a 360 degree vision of regulatory and pharmaceutical activities. The consultants of Atessia are experienced pharmacists who understand the industry and the challenges, keeping the organization up to date with changes. The company believes that it is crucial to anticipate the risk factors in the industry, be proactive in identifying ways to prevent them, and develop an action plan to face the threats. It also ensures that the services they offer have a human touch that innovation cannot replicate. Keeping in mind its code of ethics, values and mission as scientists and pharmacists, Atessia continues its journey as a leader in the industry.