A recent article from PRWeb details the new Federal regulatory requirements facing the Life Sciences Industry. The industryâ€™s implementation of a new document standard, called the electronic common technical document (eCTD), will require companies to capture all documents, variations, amendments and renewals in one consistent electronic format.
â€œBeginning January 1, 2008, the FDA will require that all electronic submissions to the Center for Drug Evaluation and Research (CDER) must use the eCTD format,â€ the November 27, 2007 PRWeb article stated.
The benefits of this new regulation include:
– Minimizes costs
– Shortened time-to-market
– Time savings and efficiencies at the FDA
Visit our website to learn how our Enterprise Quality Management (EQM) can assist you in meeting these new FDA regulatory compliance reporting requirements.