Webseite regulanet.com

Small Medium Enterprises - SMEs

EMEA

 The European Union recognises the key part that micro, small and medium-sized enterprises (SMEs) play in the innovation of new medicines and the benefit that these provide for patients. At the same time it  acknowledges that SME's do not have the same resources as larger companies. So in 2005 the EU introduced financial and administrative help for SMEs.

• Dr. Regenold GmbH can assist   companies with applications to achieve SME status and access the incentives available.

FDA

 The Food and Drug Administration (FDA) is a large, complex organization which requires a good understanding of which processes are relevant for a  specific project - this requires FDA specific  expertise for the different product categories. 

The regulanet® member in the US have local expertise and access to experts who provide this. In addition, the US regulanet® member

• Represents international companies as the designated US agent.
• Liaises with the FDA to resolve issues and expedite marketing approvals
• Prepares and submits Drug Establishment Registration/Renewals and Drug Product Listings
• Manages and inputs study information into the FDA database of investigational protocols for the treatment of serious and life threatening diseases