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Small and Medium-sized Enterprise (SME) status

Many of the innovative companies we support are Small and Medium-sized Enterprises (SMEs). These companies rely on us to be their regulatory partner and guide them through the regulatory pathway in Europe.

We recognise these companies face unique challenges in terms of their often-changing priorities and their need to provide development support which addresses their corporate objectives.

We are a registered SME

This means we can support your regulatory submissions to the European Medicines Agency (EMA). For our US clients, who do not have a legal entity based in Europe, partnering with us is invaluable to them benefiting from the additional support and fee reductions the EMA offers.

How we can help SMEs

  • We have decades of experience navigating regulatory agency interactions and regulatory submissions in Europe; from scientific advice to paediatric development, to the marketing authorization application itself. This means we can confidently guide you through your mandatory regulatory milestones.
  • As scientists, we designate time to build a foundational knowledge of your product and data so that we can always act in your best interest, fit seamlessly into your day-to-day activities, and become an extension of your company.

Questions you may have as an SME

  • Are there specific regulatory advantages for SMEs that we can leverage?
  • How can we effectively allocate resources to regulatory aspects of our product development?
  • Do we have a good understanding of the regulatory pathways specific to SMEs?
  • Of the benefits related to SME status, which are the most useful?
  • How can we prepare for market access and commercialisation of our drug/biologic?
  • What are the benefits of having a regulatory affairs consultancy guide our SME application and development programme?
  • What could we gain from using an SME consulting service?

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