SME Representation With European Medicines Agency

SME Representation With European Medicines Agency

LucyJRobertshaw AB is registered as SME (Small and Medium-sized Enterprises) by the European Medicines Agency and can support non European economic area (EEA) enterprise by accessing micro, small and medium sized enterprises (SMEs) incentives granted by the EMA through the LucyJRobertshaw AB) SME status, per the Commission Regulation (EC) 2049/2005 and EMA user guide for SMEs.

If your organisation is outside the European Union and is interested in selling your product in Europe you must register this with the European Medicines Agency.

We can help you access European Medical Agency SME office which means you can have an open dialogue and navigate their services. 

EMA’s SME office offers guidance through advising, directing and liaising SMEs with relevant scientific and regulatory contact points within EMA.

By helping smaller companies find their way through the centralised authorisation procedure, EMA requirements and other procedures, the SME office facilitates medicines development and applications for marketing authorisation.

Recent News

News

A vast translation and rework project which helped ensure the client could continue to sell its medical device products across Europe.

The client Develops, manufactures and supplies medical devices aids to support people with disabilities. Thecompany’s product range is designed to be used between patients and caregivers and are used byorganisations across Europe’s health and social care sector. “We are one of the leading European companies in this sector,” explains the

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Are we in the perfect storm?

“Is there a perfect storm on the horizon again as elective surgeries were cancelled due to patients being admitted with Covid-19? We now have a long backlog of people who are presenting with chronic diseases that need to access healthcare again”, writes Lucy Robertshaw in a column. Lucy Robertshaw, CEO

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contact us

Address:

Address: AL 31, 153 92 Hölö, Sweden.

Phone: +46 (0)706280230

Email:  info@lucyjrobertshaw.com