Aligning regulatory activities to strengthen Aguettant’s competitive position
Aguettant is an integrated specialty pharmaceutical company dedicated to the development and the commercialization of essential hospital medicines mainly in movement disorder & Parkinson disease, critical care, anesthesiology and parenteral micro-nutrients.
One year after completing its rollout of Ennov’s EDMS, workflow and eCTD publishing solution, Aguettant undertook an initiative to implement a Regulatory Information Management (RIM) system. Based on the success they realized with Ennov previously, Aguettant forwent commercially available RIM software and instead partnered with Ennov in the co-development of what today is Ennov RIM.
During this collaboration, Ennov worked closely with Aguettant to meet their primary objectives:
- Provide a structured, complete and centralized repository for product registration information
- Plan, track and analyze all regulatory, market access, pharmacovigilance and advertising activities to effectively streamline the lifecycle management of their products
- Prepare the organization for ISO IDMP
“It’s really nice to work with a software publisher that shows a great deal of innovative spirit, has great ambitions and is proactive. Above all, I really appreciate Ennov placing particular emphasis on the listening experience of the customer. ”
Cyrille JEUNE, Regulatory Affairs Systems Manager