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Centers for Disease Control and Prevention (CDC) Selects Certara to Develop Technology Platform to Strengthen the Agency’s Death Investigation and Surveillance Systems

PRINCETON, NJ – March 5, 2019 – Certara will partner with CDC to create OpenMDI (Open Medicolegal Death Investigation), a national system that will collect and share mortality data efficiently, allowing CDC to respond rapidly to critical public health priorities, such as tracking and understanding the toxicology behind drug overdoses from opioids.
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Solution: Regulatory & Medical Writing
Therapeutic Area: Central Nervous System
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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.

Solution: Regulatory & Medical Writing
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Achieving Compliance with the FDA’s eCTD Mandate

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, […]

Author(s): Rob Labriola
Solution: Regulatory & Medical Writing
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Best Practices for a Successful eCTD Submission

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, […]

Author(s): Rob Connelly
Solution: Regulatory & Medical Writing
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Things About eCTD You May Not Have Known

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 […]

Author(s): Rob Connelly
Solution: Regulatory & Medical Writing
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Avoiding Pitfalls in Plain Language Summaries of Clinical Trial Results

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.

Speaker(s): Tatyana Wanderer, Behtash Bahador
Solution: Clinical Transparency & Disclosure, Regulatory & Medical Writing
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