ELC GROUP, one of the fastest-growing providers of regulatory affairs consulting services, today announces that the National Agency for Medicines and Medical Devices (NAMMD) has issued ELC Group with accreditation to conduct Readability Testing in Romania. ELC Group is one of only three companies currently authorised to test patient information leaflet (PIL) readability for products targeting the Romanian market.
A European Directive which came into force in 2005 requires marketing authorisation holders of medicines to have all patient information leaflets for their products readability tested, ensuring that product information is legible, clear and easy to use.
Following a lengthy accreditation process, the NAMMD approval allows ELC Group to conduct PIL readability testing in accordance with the latest EU and national requirements. Pharmaceutical companies and Marketing Authorisation Holders (MAH) can now engage ELC Group to help launch products across Europe, now including the difficult to access Romanian market.
ELC group has developed extensive knowledge of readability testing and PIL writing experience since early 2007. ELC’s PIL review and editing service complies fully with QRD (Quality Review Document) and Readability Guidelines for optimal readability.
Commenting on the NAMMD accreditation, Marco Rubinstein, CEO of ELC Group said: “With our new accreditation from NAMMD, we are proud to be one of only three companies with permission to currently test readability in Romania. We have been working with Romanian and EU Commission authorities to secure accreditation for nearly three years, so I am very pleased to announce this expansion of our EU reach. This will allow ELC to offer a fast and efficient regulatory compliance service for pharmaceutical customers worldwide with an interest in engaging in Romania.”
About ELC Group:
ELC GROUP is a full-service global provider of regulatory affairs consultancy. ELC GROUP delivers a complete service solution covering all aspects of Regulatory Affairs for medicinal products, medical devices, cosmetics, food supplements and foods for special medicinal purposes. ELC GROUP also provides specialist REACH regulatory services to the Chemical industry and Corporate Language solutions for Automotive, Chemical and Defense industries.
ELC GROUP’s worldwide network of professionals spans all major Regulatory Affairs services across the key healthcare vertical markets of Pharmaceuticals, Biotech, Clinical, Consumer Healthcare, Medical Devices, Nutraceuticals and Veterinary. The team ranges from former FDA investigators to individuals with over 30 years of industry experience and broad capabilities, including in the areas of integrated advanced technologies, Regulatory Affairs consulting and commercialisation services.
ELC GROUP works with equal success in partnership with large multi-nationals, small enterprises and start-ups, biotechs, CROs and device manufacturers.