Building An Innovative and Streamlined Approach to End-to-End Regulatory eSubmissions

SCRIP Regulatory Affairs
September 2015
Author: Darryl Clarke, Sciformix Corporation

As International regulatory bodies continue to make strides towards standardizing the format and content of drug approval dossiers, pharmaceutical companies are coming under increasing pressure to improve the efficiency and quality of their regulatory operations and submission teams, particularly as an failure to comply can lead to costly penalties.

Pharmaceutical organizations must increasingly be able to manage simultaneous, multi-market product launches. Global, timely and complex submissions require thorough knowledge of all prevailing regulatory requirements as well as streamlined internal processes ranging from document management through to mitigation of potential deadline delays. This all required open communications between submission departments and all dossier content authors/stakeholders.

The industry has made great progress towards harmonizing these requirements. The adoption of standards like common technical document (CTD) and electronic common technical documents (eCTD), and non e-CTD electronic submissions (NeeS) has simplified and streamlined interactions between companies and regulators in many regions around the world including the EU, the US, Japan and Canada.

But more is needed, and companies will have to take action to comply with the evolving regulatory mandates, cope with higher volumes and manage the resources that are spread across multiple geographies.

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