Areas of Expertise
We help pharmaceutical, biopharmaceutical and biotechnology companies develop small molecules and biologics. Our expertise includes supporting companies that are developing cell and gene therapies and advanced therapy medicinal products (ATMPs).
Often, we work on medicines (especially in oncology or orphan diseases) where the development plan is very different to the traditional model. This includes submitting MAAs based on: Phase 1 or 2 data; using basket or umbrella studies; and accelerated, conditional or exceptional approvals.
As a registered Small and Medium-sized Enterprise (SME) ourselves, we have a particular affinity for helping SMEs develop innovative medicines for patients. We can help clients who do not have a legal entity based in Europe, benefit from the additional support and fee reductions the EMA offers.
Our regulatory expertise covers:
- Oncology and Haematology,
- Rare Diseases,
- Ophthalmology,
- Advanced Therapy Medicinal Products (ATMPs),
- Cell and Gene Therapies,
- Small and Medium-sized Enterprises (SME).
We are scientists first and foremost and the regulatory expertise we provide you with is driven by our nuanced understanding of your data.
Flexible regulatory expertise from start to finish.
Whatever your needs, we are your trusted life sciences partner:
- Short-term (3–6 months), discrete projects to address a particular need for resources or expertise.
- Long-term (12–24 months) projects, such as an MAA, new drug application or biologics license application.
- Ad-hoc or complex development expertise if you are developing cell and gene therapies, you are a small and medium-sized enterprise (SME) or you are developing medicines for rare diseases.
Oncology and Haematology
Rare Diseases and orphan designation
Ophthalmology
Advanced Therapy Medicine Products (ATMPs)
Cell and Gene Therapies
Small and Medium-sized Enterprise (SME) status
years of regulatory expertise
clients supported
agency interactions
orphan applications
marketing applications
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