- Registration as a Small or Medium-Sized Enterprise (SME) at EMA
- Application for Orphan Drug Designation at EMA
- Scientific Advise meeting with EMA and national regulatory authorities in Europe
If you want to increase the likelihood that competent authorities are in line with your clinical trial plans and accept your data generated to date, one of the best ways to proceed is meeting the authorities to obtain their Scientific Advice. In case you have only limited experience in communicating with authorities, or if you would like to focus on the science and therefore delegate the procedural work, Lumis Consult is here to support you. We like to learn about your investigational product and take care of preparing Briefing Documents. We know how to organise, conduct and follow-up on Scientific Advice meetings with national authorities and EMA.
If you look for EMA incentives to substantially reduce costs of regulatory fees, we offer procedural support for your company to register as a small or medium-sized enterprise (SME). We have also experience in successfully applying for orphan drug designation at EMA. Lumis can guide you through or even lead the process for you.