Regulatory Consulting and Services

Regulatory support and consulting
  • Increase chance of regulatory approval of your drug development plans
  • 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 prepare, organise, conduct and follow-up on Scientific Advice meetings with national authorities and European Medicines Agency (EMA). We help you prepare the needed documents and guide you through an efficient process for regulatory acceptance.

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 designation at EMA for product developed in rare diseases and to take advantage of the incentives provided by the EMA. Our experts provide full support to formally apply for the orphan designation and coordinates the meetings with the EMA.

Increase chance of regulatory acceptance

Substantially reduce project risks

Enhance likelihood that authorities agree with your plans

Get the most out of scientific advice

Be expertly prepared for discussions with authorities

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

We guide you through

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 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

Specialist support for SMEs

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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    Frauke Bach

    Dr. Frauke Bach

    Project Manager

    Phone: +49 30 235911-599

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

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