Lumis International –
your clinical gateway to Europe
Lumis International was founded in 2013 with the goal to offer legal representation for non-European biopharmaceutical and medical device companies when conducting clinical trials in Europe without having a local presence. As required by the EU Clinical Trials Regulation 536/2014 Art. 74 and the former EU Clinical Trial Directive 2001/20/EC Art. 19 (1) each clinical trial needs to have a legal representative.
The customers of Lumis are organisations at all different sizes ranging from small virtual clinical stage start-up companies to publicly traded late stage clinical trial companies from all over the globe.
Lumis, having itself an SME (small-medium enterprise) Status with the European Medicines Agency (EMA), can act as your agent to obtain the SME status if eligible.
With the implementation of the General Data Protection Regulation (GDPR) 2016/679, Lumis offers the services as Data Representative according to Article 27 of the guideline.
Business Development India
Razia Fatima Imran is a Business Development professional with over 15 years in the Life Sciences industry. She supports Lumis’ Business development activities in India and USA.
Her expertise ranges from promoting Sales in the Pharmaceutical and Clinical Research Organizations sector to mediating negotiations overseas and onshore.
She works as an independent consultant for Healthcare companies by outsourcing & partnering with Indian customers & counterparts.