Confidence Beyond Compliance

PharmaLex offers full electronic submission services with regard to eCTD preparation, publishing and submission activities in Europe, US, Switzerland and international eCTD adopters like the countries of 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 10 years.

Starting on May 5th 2018, FDA requires all new Drug Master Files as well as all documents submitted to existing DMFs, to be submitted in an electronic format. In this matter the FDA has published eCTD guidance that applies to all DMF submissions. The Electronic Common Technical Document (eCTD) is the standard method for submitting to FDA. This includes Drug Master Files (DMFs), Biological Product Files (BPFs) and other master files. If the submission does not occur in eCTD format after the 5th of May 2018, FDA will reject it. There will be no waivers or exemptions.

We are capable of preparing submissions of DMFs and BPFs in line with the FDA regulation. By analyzing your existing files and evaluating pre-submission considerations we place great value on the effective and efficient transition of your DMFs to eCTD format. This includes the close alignment with eCTD requirements in the EU and world-wide for broad re-use of eCTD submissions.

PharmaLex eSubmission services include consulting services in all areas of Regulatory Operations, e.g. transition to electronic submission, compliance with eSubmission roadmap, submission process optimization, implementation of efficient Regulatory Information Management (RIM), compliance with XEVMPD and IDMP requirements as well as other innovative topics in the framework of Regulatory Operations.