As your EU Consultant Obelis will:
- Become your EU Responsible Person
- Perform Formulation Review
- Compile Product Information File (PIF)
- Conduct Labelling Review
- Verify your Claims
- Secure your Safety Assessment
- Complete CPNP Notification
Once products have been registered (notified), the EU Responsible Person should also provide:
- Ongoing Regulatory updates & EU Market Consultancy
- Post-Marketing Surveillance: reporting of Serious Undesirable Effects (SUE), support regarding any EU Competent Authority requests, corrective measures,
- Immediate corrective measures, withdrawal/recall if appropriate in case of non-compliance.
- Immediate information to competent authorities (CA) and other economic operators in case of risk to the protection of human health.
- Provide information and documentation to demonstrate conformity as per requests by national authorities. Keep the PIF readily accessible to the Competent Authorities for a period of 10 years after the last batch was placed on the market.
Our team of lawyers, chemists, pharmacists, and other experts represents the largest centre in Europe for CE Marking and EC REP services.
Founded in 1988, Obelis is certified by ISO 9001:2015 and ISO 13485:2016, and partakes in various EU associations and EU commission working groups.