Phone: +44 141 899 0081

Our Services

CHMP Oral Explanation MAA

EMA Solutions provides high quality assistance on planning the initial MAA submission strategy as well as support at Day 120, 150 and 180 questions. We can support or represent clients at the OE meeting.

COMP Oral Explanation Orphan Drug

Our epidemiologists, former COMP members & senior industry executives of EMA Solutions help address the COMP questions and support clients at the OE meeting.

PDCO Oral Explanation PIP

At EMA Solutions, we can help you with all the preparation before meeting with the Rapporteur and PDCO.

PRAC Oral Explanation or Public Hearing

EMA Solutions can provide our international team of experts to support your planning for an OE at PRAC.