- 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.
Testimonials
“Lumis’ expertise in medical device regulations and clinical affairs proved highly effective for our project. Not only did we obtain swift approvals with minimal queries but the Lumis team maintained regular communication – ensuring we had full transparency on the project’s progress“
~ Zilia Inc, September 2024
“We very much appreciated Lumis’ flexibility, expertise, and their prompt responses. Additionally, we appreciate their proactive work ethic. They worked harmoniously with us and the investigator site by leading the CTIS submission, resulting in a timely approval, without many RFIs, for our study in Denmark.”
~River3Renal, July 2024
“Lumis’ expertise was evident throughout our project as they navigated unique regulatory challenges due to the nature of the study. They were proactive and communicated regularly throughout the project and swiftly answered all our questions. With their strengths, they made a successful submission which was subsequently approved.”
~1ST Biotherapeutics, Inc., July 2024
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.
