PRINCETON, NJ – February 4, 2019 – Certara today announced that Justin Edge has joined Certara as President of Synchrogenix, the company’s regulatory science division.
Certara’s Synchrogenix Division Collaborates with Hedera Hashgraph to Offer Data Flow and Transparent Collaboration Solutions for the Life Sciences Industry
October 15, 2018 – Certara today announced that it has formed a strategic collaboration with Hedera Hashgraph. Synchrogenix®, Certara’s regulatory sciences division, has been building distributed applications in the life sciences and healthcare markets that will expand its reach in the areas of transparency and disclosure, regulatory reporting and data sharing, and collaboration/communications from drug development through market access.
FDA Renews and Expands Its Use of Certara Software to Facilitate New Drug and Biologics Regulatory Review
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.
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, […]
In this webinar, Steve Sibley defined best practices for establishing submission timelines that won’t change, addressed regional differences to minimize document re-work when submitting to multiple countries, and identified leadership and project management skills helpful to regulatory writing.
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, […]
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 […]
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.
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 […]