Achieving Compliance with the FDA’s eCTD Mandate

Rob Labriola

The US Food and Drug Administration (FDA) has set May 5, 2018 as the compliance date for submitting many types of files—Drug Master File (DMFs) and commercial investigational new drugs (INDs)—in the electronic Common Technical Document (eCTD) format. A DMF provides confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, […]

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Topics: Regulatory Submissions Management

Best Practices for a Successful eCTD Submission

Rob Connelly

The eCTD struggle is real. Regulatory submissions must conform to the electronic common technical document (eCTD) format to be successfully received and reviewed by health authorities. And while this might seem simple, this complex technical process is actually rife with risk if you lack expertise in medical writing and regulatory publishing. In this blog post, […]

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Topics: Regulatory Submissions Management

Things About eCTD You May Not Have Known

Rob Connelly

In helping clients with their regulatory operations and electronic publishing needs, I’m often asked about preparing regulatory submissions in the electronic common technical document (eCTD) format. While a lot of us have been working in the eCTD format for many years, new start-up companies focusing on rare diseases and new technologies to treat patients are […]

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Topics: Regulatory & Medical Writing, Regulatory Submissions Management

GlobalSubmit Submissions Management Software and Services

Facilitating Regulatory Submissions Due to the enormous amount of information in a drug marketing application, regulatory agencies require sponsors to submit applications electronically in formats that facilitate their review, such as the Electronic Common Technical Document (eCTD). To comply to the complexities and requirements of electronic submissions, regulatory teams need to complement their expert staff […]

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