EU pharmaceutical legislation requires that Sponsors are established in the EU/EEA in order to conduct specific activities (e.g., clinical trials), act as an applicant/holder for Orphan Drug Designations and Marketing Authorisations or to access Small and Medium Size Enterprise (SME) benefits.
To help you access and navigate the EU regulatory system, DLRC provides a full range of EU representative services. These are efficiently delivered by Orphix Consulting GmbH – a member of the DLRC Group of companies.
For foreign sponsors looking to comply with FDA regulations in the US, a US Agent is required for a number of activities related to drugs and biologics. DLRC can provide US Agent services to act as a communication link between FDA and the foreign sponsor, expertly delivered by DLRC, Inc., a member of the DLRC Group of companies.
By choosing DLRC Group as your representative, you can access and interact with EU and US regulatory systems more effectively, with an expert team on-hand to support your regulatory strategy.