Regulatory services

Regulatory services

Product
Regulatory services
Regulatory services

Information

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).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.
Distribution Areas
North America (USA, Canada)Middle East Region (e.g. UAE)Europe - EU countriesEurope - non EU (e.g. UK, Russia, ex-CIS countries)
Main Categories
Contract Development and Manufacturing Organisations (CDMOs) and Contract Manufacturing Organisations (CMOs) (Services)
All Categories
Regulatory Affairs
Content GroupWe are an all-Italian pharmaceutical CDMO founded around content, the constant focal point of everything we do: liquid (such as solutions, suspensions and microemulsions), gel and lyophilized pharmaceuticals, medical devices and cosmetics, both for human and veterinary uses and especially for ophthalmic but also for nasal, oral, respiratory, otological, dermatological and diagnostic sectors. With decades of experience in the ophthalmic and respiratory sectors, we boast 2 companies: C.O.C. Farmaceutici and Tubilux Pharma.

Log in

See all the content and easy-to-use features by logging in or registering!