Support for Scientific Advice Meetings

Regulatory support and consulting
  • 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.

Increase chance of regulatory approval

Substantially reduce project risks

Enhance likelihood that authorities agree with your plans

Get the most out of scientific advice

Get the most out of scientific advice

Delegate procedural work

Let us relieve you from complex formalities

Reduce costs of regulatory fees

Register your company as small or medium-sized enterprise (SME)

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.

Contact our experts to find out more!

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    We look forward to giving you the best possible support for your Scientific Advice Meetings.

    Dr. Christiane Juhls

    Project Director Lumis Life Science Consulting GmbH

    Phone: +49 30 235911-599

    We look forward to helping you find your best fit in outsourcing your clinical trials!

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