ATESSIA is an innovative company that can help you innovate and access the European market!
SMEs are a driver of innovation in the pharmaceutical sector and play a key role in the development of new medicines.
But for small companies, finding their way through EU rules and regulations can be a challenge.
ATESSIA is SME certified by the European Medicines Agency.
The SME initiative has been put in place by the EMA in order to promote innovation and the development of new medicinal products by smaller companies.
The EU incentives offered by EMA apply to both the human and veterinary sectors, and include:
- Regulatory, administrative and procedural assistance from the Agency’s SME office including SME briefing meetings
- Fee incentives (reductions, exemptions) for regulatory procedures such as Scientific advice on medicine development plans, MA applications, Inspections.
- After MA approval, EMA also provides translations of product information in all EU languages, free of charge.
ATESSIA can make non-EEA SME companies benefit from the European Medicines Agency SME incentives : SME regulatory consultancies may seek to benefit from the provisions of the SME Regulation on behalf of non-EEA based clients, if both they and the client meet the SME criteria:
Headcount: The company and its subsidiaries should have less than 250 employees
Financial thresholds: Annual turnover ≤ € 50 million or Balance sheet ≤ € 43 million