Each package bundles the regulatory documents, testing, safety assessment, notification and Responsible Person coverage you need to legally sell in that market. Pick the depth that matches where you are in the launch.
EU Packages
Choose your EU compliance package
Basic
For EU ready products.
✓Formula compliance review
✓Product information file review
✓Labeling and claims review
✓CPNP notification
–Safety assessment (CPSR)
–Microbiological specifications of the finished products
–Stability and compatibility test
–Challenge test
Approximate turnaround time: 1 week
Recommended for
Companies interested in changing the RP, companies that are fully compliant with EU related regulations that would want to expand into the EU.
Full-service compliance for established brands and complex portfolios.
✓Formula compliance review
✓Product information file preparation
✓Labeling and claims review
✓CPNP notification
✓Safety assessment (CPSR)
✓Microbiological specifications of the finished products
✓Stability and compatibility test
✓Challenge test*
*Not mandatory for anhydrous products
Approximate turnaround time: 15 weeks
Recommended for
Companies just starting business, companies without their own laboratory facilities, companies that want to focus only on sales and completely outsource regulatory and testing.
Full-service compliance for established brands and complex portfolios.
✓Formula compliance review
✓Product information file preparation
✓Labeling and claims review
✓CPNP notification
✓Safety assessment (CPSR)
✓Microbiological specifications of the finished products
✓Stability and compatibility test
✓Challenge test*
*Not mandatory for anhydrous products
Approximate turnaround time: 15 weeks
Recommended for
Companies just starting business, companies without their own laboratory facilities, companies that want to focus only on sales and completely outsource regulatory and testing.