Regulatory services
State-of-the-art products
Thanks to the experience we have gained during these decades in the pharmaceutical sector, we offer a series of auxiliary services in addition to manufacturing and packaging.
For medical devices, we offer support for regulatory services such as:
- drafting of technical dossiers
- drafting of clinical evaluations
- registration with the Italian Ministry of Health database
- CE certification for all European Union countries
- Free sale certificate for distribution in non-EU countries
For pharmaceutical products, we offer support for regulatory services such as:
- registration via national and European Union procedures
- ANDA registration
- drafting of e-CTDs to create e-CTD sequences
- regulatory compliance
- minor and major variations (evaluation and/or management)
We are specialized in
private label
private label
We offer customers a complete range of medical devices for nasal and eye care, ready for customisation with the graphics and brand of the distributor.