Developing a winning regulatory strategy for Orphan Designation across the EU, USA and APAC.
Pharmaceutical and Biotechnology Regulatory Consulting & Services
Tailored Solutions, Streamlined Submissions: Your Regulatory Advantage
Lumis International provides expert regulatory consulting and services streamlining pharmaceutical and biotechnology development. Our proven solutions can help you reduce regulatory costs and speed up drug development, getting your products to patients faster.
We specialise in the pre-approval stages (e.g. orphan designation, science advice, clinical trials, pediatric planning, innovative designations) and focus on EU and UK markets. Our small, agile team is ideal for small and medium-sized medical companies.
We tailor our services to your needs, whether writing regulatory documents, managing submissions, or providing ad-hoc support. Our unique blend of state-of-the-art project management tools with regulatory expertise ensures timely, cost-effective, and high-quality results.
With over 10 years of experience, Lumis is known for quality customer service and expertise, earning a reputation as a trusted regulatory partner for pharmaceutical and biotechnology companies. Contact us today to learn how we can be your trusted regulatory partner.
Our 3E Advantage: Expertise. Efficiency. Expedited.
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Leverage Expertise
Leverage our regulatory & project management expertise for cost-effective delivery.
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Delegate Tasks
Focus on scientific innovation and leave the complex regulatory burden to us.
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Accelerate Access
Harness our proven strategies to navigate regulations and fast-track market entry.
Regulatory Consulting
Our small, agile team of regulatory consultants is perfectly suited to small and medium-sized biotech and medical device companies. We customize our services and approach to fit your specific needs.
We specialise in the pre-approval stages of the lifecycle and focus on the EU and UK markets.
Regulatory Strategy Consulting
Our experts devise UK & EU regulatory strategies for your product’s development that are tailored to the technology and your company objectives. We blend scientific rigour, regulatory incentives, regulator interactions, and European/national requirements into our regulatory consultant strategies, ensuring a compliant path to market and long-term success.
Factors we consider for your strategy:
- Product classification – small molecule, biological, Advanced Therapeutic Medicinal Product, radiopharmaceutical, etc.
- Applicable European and national requirements
- Regulator interactions – e.g. science advice options and early regulator interactions, such as the Innovation Task Force.
- Regulatory designations – Orphan designation, PRIME (EU), ILAP (UK), SME Status, etc.
- Clinical, nonclinical, and CMC development strategy
- Market authorisation route
Orphan Drug Applications
Orphan designation incentivises the development and approval of rare disease treatments. With our deep expertise, we handle your application and manage the IRIS submission procedure.
How we can help:
- Preparation of the EMA scientific document (sections A-E)
- Consolidation of supporting data (including a literature review)
- Management and submission of the application via the IRIS portal
Sponsors of EU Orphan Designations must be based inside the European Economic Area (EEA). However, if you are based outside of the EEA we act as your EU-based Orphan Designation Sponsor, giving you access to a host of orphan designation benefits.
Check out further resources:
- Check out our webinar on orphan designations to gain useful insights for rare diseases.
Science Advice Meetings
By aligning with regulators on your project’s scientific development, you enhance its scientific robustness, strengthening subsequent regulatory applications.
How we can help:
- Prepare briefing packages
- Manage the submission procedure
- Lead preparation for regulatory meetings for both EU centralised or national level advice.
Check out further resources:
- Check out our webinar on science advice.
Clinical Trials
Whether it’s an initial application, transition from the Clinical Trials Directive, addition of a member state, or another maintenance submission, we support your study – saving you time and effort. As your regulatory consultant of choice, we help clients navigate the complex EU Clinical Trial Regulation (EU) 536/2014 and associated Clinical Trials Information System (CTIS).
How we can help:
- Medical writing – protocol, IMPD, patient information sheets and informed consent forms, investigator brochures, and clinical study reports
- Prepare and submit applications via CTIS on your behalf
- Acting as the legal representative for non-EU sponsors. Find more information here:
Check out further resources:
- Check out our blog on EU CTR transition applications.
Paediatric Investigation Plans
Paediatric Investigation Plans (PIPs) outline the development of medicines for children and are required for new medicines. Developing pediatric medicines is complex and requires specific expertise. Lumis guides you through the nuances of the PIP process, helping to shape your paediatric strategy.
How we can help:
- Compile supportive data (including literature review)
- Write the Paediatric Investigation Plan
- Manage the submission procedure
- Lead in the preparation of any science advice meetings (see science advice services above
Other Services
Benefit from our broad regulatory expertise to engage with regulators earlier, leverage regulatory incentives, and ensure a robust regulatory strategy.
- ATMP classification procedure
- Early regulatory interactions (Innovation Task Force, UK Innovation Office)
- Innovative regulatory designations – PRIME (EU), ILAP (UK)
- SPOR account management
- SME status applications
- Specialised Medicines – radiopharmaceuticals
Contact us to find out more!
Testimonials
- 1ST Biotherapeutics, Inc., July 2024Lumis’ 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.
- River3Renal, July2024We very much appreciated Lumis’ flexibility, expertise, and their prompt responses. Additionally, we appreciate the pro-active working ethics. 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.
- Small German Biotech Company, June 2024Lumis Consult provided great support and helpful advice to successfully add a new member state to our clinical trial in CTIS – this allowed us to expand our trial and recruitment capabilities.
Latest news & blog articles
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