Interactions with Regulatory Bodies

Interactions with Regulatory Bodies

RLM Consulting has direct contacts with most EU national agencies and the EMA; this allows quick feed-back on questions raised by our customers. We have also a long experience in preparing for, and assisting clients for Podiatric Investigation Plan, scientific advice, pre-submission meetings and hearings. This involves the anything of the related briefing documents.

We have been successful in getting the EU Orphan Drug status for a number of compounds and indications.