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Achieving Compliance with the FDA’s eCTD Mandate

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, […]

Author(s): Rob Labriola
Solution: Regulatory & Medical Writing
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Best Practices for a Successful eCTD Submission

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, […]

Author(s): Rob Connelly
Solution: Regulatory & Medical Writing
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Things About eCTD You May Not Have Known

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 […]

Author(s): Rob Connelly
Solution: Regulatory & Medical Writing
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Avoiding Pitfalls in Plain Language Summaries of Clinical Trial Results

In this webinar, Tatyana Wanderer and Behtash Bahador provided insights and recommendations gained from working with leading sponsors on portfolio-wide implementation and pilot programs to create plain language summaries of clinical trial results.

Speaker(s): Tatyana Wanderer, Behtash Bahador
Solution: Clinical Transparency & Disclosure, Regulatory & Medical Writing
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How AI Tech Is Changing Regulatory Writing

Did you know that you’re likely using artificial intelligence (AI) in your everyday life? For example, the digital music service, Spotify, creates “mood-based” playlists that are curated to users’ musical preferences. Spotify generates these customized play lists using a machine learning algorithm that has learned your unique musical preferences based on your previous interactions with […]

Author(s): Nirpal Virdee
Solution: Clinical Transparency & Disclosure, Regulatory & Medical Writing
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Best Practices for Complying with EMA Policy 70

EMA Policy 70 requires sponsors to publish anonymized versions of clinical study reports (CSRs) and submission documents submitted in support of a marketing authorization application (MAA) after January 1, 2015. Sponsors must prevent re-identification of people named or referred to in those documents. In March 2016, the detailed guidance document was published. This blog post […]

Solution: Clinical Transparency & Disclosure
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