During the various phases of medicinal product’s development, the accompanying documentation is evolving as well. The culmination of medicinal product’s development is the entry into the market which is accompanied with such documents as Summary of product characteristics (SPC) and Package leaflet (PL).

Because the format and contents of SPC and PL are strictly regulated and will be reviewed by regulatory authorities when applying for marketing authorization, we can make sure that your documents are of high quality and fully compliant. Our medical writers have the expertise to make sure that the SPC of your product has scientifically sound language and the PL is easy to read and is understandable to the patients.