Regulatory Support
SIMS - Società Italiana Medicinali Scandicci

SIMS is capable to offer to its customers a complete regulatory support.

With exports to the main regulated markets, including USA, UE, Japan, Australia and several others our skilled personnel maintains regulrar contacts with the concerned local Health Authorities and is able to ensure quick and exhaustive responses to any specific request.

There are actually 20 active DMFs (of which 10 already in eCTD format) and 10 CEP: we have a firm commitment to maintain these documents updated according to most recent Guidelines.

Our regulatory activities also comprise the compliance to REACH legislation.