Enhancing eSignature Legitimateness for Pharmaceutical in European Union

How to eSign a document: eSignature legitimateness for Pharmaceutical in European Union

[Music] small and medium-sized enterprises or SMEs are the backbone of Europe's economy they 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 sometimes be a bit challenging so if you are an SME in the pharmaceutical sector we're here for you the European Medicines Agency or EMA has a dedicated office to support companies like yours first of all you need to have SME status assigned by EMA now what do you need for that you need to be a registered company in an EU country and meet the definition of an SME what makes you an SME in the European Union your company in its subsidiaries should have less than 250 employees and either the annual turnover is no more than 50 million euros or the balance sheet total is no more than 43 million euros as a registered SME you can benefit from free incentives for regulatory procedures submitted to EMA such as scientific advice on medicine development plans marketing authorization applications or inspections when your medicine has reached the stage of marketing authorization EMA provides translations of product information in all EU languages free of charge you can also take part in our training sessions and receive newsletters and updates on various regulatory topics the SME office can also advise you on the support available during the development of medicines for human and veterinary use have a look at our website and find out what the EMA SME office can do for you [Music] [Music]