Obelis


Obelis European Responsible Person Center (O.E.R.P.C.) is a quality driven, ISO 9001:2008 certified, service oriented company based in Brussels, Belgium with almost 30 years of experience with the European Regulations.  Obelis operates as one of the largest regulatory centers today, providing “EU Responsible Person” and Cosmetic Notification services in Europe. 
The "Responsible Person" must ensure compliance with requirements of the EC Cosmetic Regulation 1223/2009. To fulfill this role, Obelis experts collect and verify all the information required for the compilation of the Product Information File (PIF) and perform the notification of the product prior to the market launch.


Obelis services include, but are not limited to:
- « Responsible Person » covering 31 EEA countries,
- Classification & Identification of Proper Regulation,
- Product Information File (PIF) Compiling, Keeping and Updating (including Safety Assessment),
- Keeping the PIF readily accessible to the Competent Authorities for the duration required,
- Cosmeto-vigilance Contact Point and communication of Serious Undesirable Effects (SUE),
- Labeling and Language Requirements covering 31 EEA countries,
- Pre-market notification to the EU Competent Authorities and Toxic Centers,
- Additional Consultancy : GMP – good manufacturing practices, GLP – good laboratory practices,
- Safety Assessment, notification of nanomaterials, animal testing.