Communications: Regulatory and Medical Writing

Communications

Strategic Writing and Compliance is Key to Successful Drug Development High quality medical and regulatory writing is an essential part of any successful drug development program. Sponsors need a trusted, agile, and experienced partner not only to write these documents, but also to provide program guidance to address key issues and opportunities. Synchrogenix has developed […]

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Operations_DEV

Synchrogenix Regulatory Submission and Publishing Services The skills needed to confidently compile an electronic regulatory submission take years of on-the-job training, industry immersion, and regulatory study to develop. Full or partial outsourcing to a proven electronic common technical document (eCTD) partner is often the most cost effective solution, and one that gives your organization the […]

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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

Operations

Synchrogenix Regulatory Submission and Publishing Services The skills needed to confidently compile an electronic regulatory submission take years of on-the-job training, industry immersion, and regulatory study to develop. Full or partial outsourcing to a proven electronic common technical document (eCTD) partner is often the most cost effective solution, and one that gives your organization the […]

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