Confidence Beyond Compliance
Beyond the provision of regulatory guidance, PharmaLex streamlines the submission management process to ensure error-free, timely and quality regulatory submissions are submitted throughout the lifecycle of each of the Marketing Authorization. PharmaLex offers full electronic submission services with regard to eCTD preparation, publishing and submission activities worldwide including international eCTD adopters such as GCC (Gulf Cooperation Council). Our dedicated team ensures the technical quality of the source documentation, the technical validity of the final submission package according to applicable global and regional eCTD specifications and requirements as well as the timely submission to the agencies via submission gateways and portals. eCTD publishing for submissions across various regions worldwide has been part of our service portfolio for over 15 years.
PharmaLex brings along extensive experience with publishing and submission activities of all kinds and formats for more than 100 companies to nearly all relevant health agencies worldwide (e.g. EMA, all EU NCA, FDA, Health Canada, Swissmedic, Saudi FDA).