
We provide “FULL-SERVICE” to our customers—and handle all regulatory requirements for you! Thanks to our experience and our global distribution network (customers), we understand just how varied the different registration requirements can be. MEDENA is your expert and handles registrations and certifications worldwide reliably and accurately.
Our service portfolio includes
Preparation, management, and submission of cosmetic documentation (PIF – cosmetic dossier) for registration, as well as production of your brands in compliance with Cosmetics GMP – ISO 22716:2007 for a wide range of products, including dermatological efficacy tests and clinical studies.
Consulting in the field of medical devices in accordance with
the European standard – ISO 13485:2016, essential requirements – risk analyses – labeling.
Compilation, management, and submission of documentation in accordance with the NATRUE guidelines for
the development, manufacture, and sale of certified NATRUE-compliant premium products.
Review of layouts regarding INCI names, product claims, and legal requirements, as well as consulting
on product labeling.
Preparation of all documents for global registration, including the issuance of Free Sale Certificates, notarized and apostilled certifications.
