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Ensuring product information is legible, clear and easy to use is key to maintaining successful communication with patients, as well as for securing regulatory approval. This not only applies to the copy but also the format, which must adhere to the relevant regional or national product information templates. Without this clarity, you run the risk of regulatory authority rejection or poor patient compliance due to a lack of understanding. Another important consideration is the markets on which your product will be placed, as for example, across the EU there is a complex translation process and linguistic review involved.
How can we help?
Our experienced consultants are able to provide advice on user testing and the readability of content and format to comply with legislation, as well as conducting user testing and preparing outcome summary reports for Module 1.3.4. For us attention to detail is crucial. We will support you at every level – from reviewing relevant texts to writing copy for the Summaries of Product Characteristics (SmPC), Package Leaflets and labelling, Company Core Data Sheets (CCDS) as well as managing translation and linguistic review processes. We are also able to create the final artwork and ensure the necessary legal requirements for blind or partially sighted people can be assessed and applied.
For a more detailed discussion on how we can help you, contact us on +44 (0)1628 530554 or email us via our contact form.REQUEST MORE INFORMATION