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

Best Practices for Writing Clinical Study Protocols

Kelley Kendle

The pharmaceutical industry has long grappled with the problem of poorly written clinical study protocols. The study protocol describes the conduct of a study, its objectives, methodology, design, and statistical considerations and ensures the safety of participants and integrity of data collected. The teams generally responsible for protocol writing are the medical writing and regulatory […]

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Topics: Regulatory & Medical Writing

Feedback from the Phoenix Community: Our Visits with the FDA

Nathan Teuscher

We recently completed a week-long set of meetings with the FDA, where we met with over 300 FDA reviewers from 7 of the 11 FDA centers that use Phoenix. Here are a few topics that took center-stage during our visits: Q: How can we create Phoenix workflow templates that are reusable across different studies with […]

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Topics: PK/PD Modeling & Simulation