The SME eligibility criteria are based on the company’s size, e.g. number of employees and annual turnover. Non EU/EEA companies can access EMA SME incentives through Assion as an EU-established SME regulatory consulting and services company.
Both us, and our EMA approved SME clients have access to significant benefits, such as administrative, regulatory and financial support including significant reductions in EMA fees for pre and post authorisation procedures like scientific advice, inspections, and Marketing Authorisation Application fee deferral.
How we support you
We will support you in assessing the SME eligibility criteria fulfilment and guide you through the benefits you might have access to.
We will coordinate the SME client status application preparation and submission. We provide the operational support by collecting the required documentation to prepare, submit the SME application and maintain the SME status. We’ll also act as the main contact point for the EMA SME office on our client’s behalf.
On demand regulatory team an Assion case study
A small-to-medium sized biotech business faced challenges right sizing and staffing an international regulatory organisation. Our client was entering new markets and as such required a significant amount of support in the pre-launch and launch years of commercialization. However, once that work was completed, the required activities would significantly reduce.