Regulatory Consulting and Services

Regulatory support and consulting
  • Pharmaceutical and Medical Device regulatory and consulting services
  • Full support – regulatory services tailored to your needs, no matter how big or small
  • Customer service – Lumis’ project management setup ensures regular, direct communication and excellent customer service

We optimise pharmaceutical and medical device development through expert regulatory consulting and services. Our tried and tested solutions can help you reduce regulatory costs and expedite approvals – thereby accelerating patient access to your medical product.

With decades of experience, our experts specialise in EU and UK regulations so we are particularly suitable if you are looking to enter these markets. Furthermore, our nimble approach allows us to tailor our services to your project’s needs. From devising and executing a regulatory strategy, managing submissions, guiding clients through complex regulatory procedures, preparing documents, or providing ad-hoc support, we can add value to your project.

Lumis has served clients for over 10 years and prides itself on excellent customer service and expertise and, consequently, has gained a reputation as a trusted partner for pharmaceutical and medical device companies. Contact us today and enquire how we can be your trusted partner in regulatory services.

Regulatory efficiency for your project

Expertise – reduce costs, expedite approvals

Our expert-level regulatory strategies can reduce your development costs and help expedite approvals

Delegate work

Let us relieve you of any regulatory work – allowing you to focus on the science

Reduce project risks

Enhance the likelihood that the authorities will agree with your plans

Our services

Our regulatory consulting and services are divided into three areas – pharmaceuticals, medical devices, and medical writing – and can be tailored to your project’s needs.

Pharmaceuticals

We can optimise your product’s development, for example, by ensuring accurate classification and utilising applicable EU and UK regulatory incentives and specialised procedures.

  • Regulatory strategy
  • Early regulatory interactions (Innovation Task Force, UK Innovation Office)
  • Innovative designations (e.g. PRIME, ILAP)
  • ATMP Classification
  • SME status applications
  • Science Advice Meetings
  • Orphan Drug Applications
  • SPOR Account Management
  • Clinical trial applications – including Clinical Trials Regulation 536/2014 transition activities
  • Paediatric Investigation Plans
  • Specialised medicines – medicinal cannabis and radiopharmaceuticals

Medical devices

With our experience in European Medical Device Regulations, we can provide support throughout your device’s lifecycle to swiftly obtain CE marking and maintain compliance.

  • Classification advice
  • Early Regulatory Interactions (UK Innovation Office)
  • Notified Body/ UK Approved Body selection
  • Risk management
  • Clinical evaluation & performance evaluation – plans and reports
  • Clinical investigation submissions
  • Technical file writing
  • QMS design and development
  • Audit preparation
  • Medical Device Regulation (EU) 2017/745 (MDR) Preparation
  • Post-market clinical follow-up

Medical writing

Our scientific and regulatory experts can write entire technical documents for you, support you in the writing process, or provide ad-hoc support. With our added expertise and capacity, preparing regulatory documents will be an easier and quicker endeavour.

  • Clinical trial documentation: protocols, investigator brochures, investigational medicinal product dossiers, patient information sheets and informed consent forms, and recruitment materials
  • Clinical study reports: full report, lay summaries

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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    Liam Spencer, Senior Project Manager

    Liam Spencer

    Senior Project Manager

    Phone: +49 30 235911-599

    info@lumisconsult.com

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

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