Press Release :

Biogaran selects Agatha to manage their Regulatory Processes and Documentation

Lyon, France; Tokyo, Japan; Boston, MA, USA – Agatha Inc., a leading provider of software solutions for the healthcare and life sciences industry, Today announces a new partnership with Biogaran, the first pharmaceutical laboratory for generic medicines in France and a subsidiary of Servier Group. This collaboration marks a significant milestone, as Biogaran has chosen Agatha to manage the entirety of its regulatory documentation and processes critical for market authorizations of their products.

Biogaran, player in the daily health of the French with a portfolio of more than 1000 references, aims to digitalize and optimize its regulatory affairs management with Agatha’s cutting-edge solutions. Agatha’s platform will facilitate the comprehensive management of submission planning, correspondences with health authorities, and the maintenance of regulatory documentation, which encompasses approximately 1 million documents to date. Additionally, Biogaran will leverage Agatha’s capabilities to navigate submission archives transmitted to health authorities efficiently.

The decision by Biogaran to adopt Agatha’s solutions was driven by the software’s usability, flexibility in adapting to existing processes, and Agatha’s strong local presence. Furthermore, Agatha’s adherence to critical regulatory compliances, including FDA CFR 21 Part 11, EU Annex 11, and GDPR, played a pivotal role in this partnership.

Guillaume Gerard, Chief Operating Officer at Agatha, Inc., expressed enthusiasm about the partnership, stating, “Agatha is thrilled to collaborate with Biogaran to enhance the management of their regulatory documentation and processes. Our shared values of speed, transparency, and trust have laid a solid foundation for a successful project, eagerly anticipated by both teams.”

 About Biogaran 

A pioneering generic medicine laboratory in France, created in 1996, Biogaran today covers a vast spectrum of pathologies ranging from everyday ailments to the most serious pathologies. With more than 1,000 references of medicines manufactured mainly in France and Europe and services intended to promote patient compliance and quality of life, Biogaran plays a major role in the health of the French.

For more information about Biogaran, visit https://biogaran.com/en/

About Agatha 

 Agatha, Inc. is a premier strategic software solutions provider to the healthcare and life sciences industries. Dedicated to supporting hospitals, biotechnology, pharmaceutical companies, CROs, and medical device firms, Agatha facilitates the optimal management of Quality, Regulatory, and Clinical documentation and processes. With solutions designed for immediate deployment, compliance with relevant regulations, and rapid scalability, Agatha helps clients significantly reduce compliance risks and enhance productivity, achieving an average of 80% reduction in time spent managing critical documentation.

 For further details, visit https://en.agathalife.com/

Contact: Yannick Piriou Email: yannick.piriou@agathalife.com

 For French language version of this press release, please click here.