Certara is the leading drug development consultancy with solutions spanning the discovery, preclinical and clinical stages of drug development.
PRINCETON, 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 MoreFacilitating 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 […]
Read MoreSynchrogenix Strategy, Regulatory Writing & Science Products and Services
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