- Increase chance of regulatory approval
- Substantially reduce project risks
- Delegate procedural work
Do you want to increase the likelihood that authorities are in line with your clinical trial plans and accept your data? One of the best ways is meeting the authorities to obtain their scientific advice. Lumis is curious to learn about your investigational product and can support you in communicating with authorities, procedural work, and briefing document preparation. We are familiar with the needs and culture of small companies and know how to organise, conduct and follow-up on Scientific Advice meetings with national authorities and EMA. We guide through an efficient process for regulatory approval.
Are you looking for EMA incentives to substantially reduce costs of regulatory fees? Lumis offers procedural support to register your company as a small or medium-sized enterprise (SME). You can also rely on us for applying for orphan drug designation at EMA.
What we can do for you
Delegate procedural work, and your focus can remain on the science. We provide you with vital resources and essential expertise.
- Scientific Advice meeting with EMA and national regulatory authorities in Europe
- Registration as a Small or Medium-Sized Enterprise (SME) at EMA
- Application for Orphan Drug Designation at EMA
Not sure what a specific regulation says or want to know more about the meaning behind a certain term? Visit our glossary.
Our expertise, your benefits
We are a small, flexible and approachable company, located in Berlin (Germany), specialized on the needs of small to medium-sized enterprises. Our experienced project managers safely navigate you through the process, always focusing on timelines and cost-efficiency. A proven track record of successful collaborations makes us confident that we find a solution to your concerns.
