FDA will only accept electronic submission!
And a miracle happens!
As of May 5, 2018, the FDA will only accept electronic submission and arivis Inc. is here to help!
At arivis Inc. the Professional Services Group (PSG), our mission is to provide continuous quality, experience, and technical knowledge for eCTD submissions by serving as a collaborative extension of our clients’ regulatory teams. We are proud to continue to support our clients throughout the life of their regulatory applications to ensure life-changing medications are brought to market while meeting internal and agency driven goals. arivis PSG has had the pleasure of contributing to treatment applications related to cancers, heart failure, major depressive disorder, along with other drug therapies, and looks forward to providing support for future regulatory applications.
Our PSG team knows how daunting a task it may seem to convert from paper to eCTD, and what that learning curve looks like; that is what we are here to help with! Our team is able to provide guidance to our clients on electronic submissions and eCTD structure as well as process the submissions on your behalf. We take our clients submission documents and process each file according to the Technical Conformance and ICH guidelines as well as add the appropriate navigation. Once the documents are fully processed, we use our newly released proprietary eCTD software to build the electronic submissions and submit through the electronic gateway on behalf of our clients.
If you are in need of a partner to make the “miracle happen” and build your electronic submissions, please contact the Professional Services Group at arivis Inc.
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Wed, 2018-04-25 15:42