REGULATORY AFFAIRS DEPARTMENT
At every step of our business development, our well-staffed Regulatory and Compliance Affairs Department remains ready and fully prepared to oversee the execution of every project.
The Regulatory Affairs Department of TOLLEON and its partner companies are responsible for:
- Developing technical dossiers and adapting them to meet specific national regulatory requirements.
- Managing approval procedures for the registration of pharmaceuticals, medical technology products, dietary supplements, and cosmetics at both national and international levels.
- Handling marketing authorizations by providing comprehensive regulatory support and overseeing all registrations with Health Authorities, including modifications and updates where necessary.
- Conducting scientific translations and preparing Patient Information Leaflets (PILs), Labeling, and Summary of Product Characteristics (SmPCs) as well as designing, approving, and ensuring compliance of packaging materials with regulatory guidelines both within and outside of Europe and the US.
TOLLEON’s Regulatory Affairs team simplifies global compliance for pharmaceuticals, medical devices, supplements, and cosmetics. We prepare tailored technical dossiers, secure international registrations, and manage all updates with Health Authorities. With precise scientific translations and fully compliant packaging and labeling, we ensure your products are approved, trusted, and market-ready worldwide.