Certara is the leading drug development consultancy with solutions spanning the discovery, preclinical and clinical stages of drug development.
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 […]
Read MoreSynchrogenix 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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Read MorePRINCETON, NJ – Oct. 9, 2018 – Certara today announced that the US Food and Drug Administration (FDA) has renewed, and in many cases increased, its number of Certara software licenses for reviewing new drug and biologics applications.
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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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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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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 […]
Read MoreSynchrogenix 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 […]
Read MoreSynchrogenix—The Full Regulatory Continuum
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