Plan to Accelerate Your Time to Drug Submissions
There are common themes driving how quickly you can get from your last database lock…
CertaraApril 20, 2021
Purity is a Virtue: A Practical Guide to the Reporting of Impurities
Many pharmaceutical companies struggle with characterizing drug substance (DS) and drug product (DP) impurities and…
CertaraMarch 23, 2021
Prelude Therapeutics reduces their quality control (QC) process for regulatory submissions from hours to minutes with Certara’s GlobalSubmit eCTD Software
In 2019, Prelude Therapeutics, a small cancer drug discovery company, implemented Certara’s GlobalSubmit submissions management…
CertaraMarch 2, 2021
Certara Acquires AUTHOR!, a Regulatory and Biostatistics Services Firm in Europe
Broadens European footprint with integrated regulatory services and statistical analysis PRINCETON, NJ.— March 2, 2021–…
CertaraMarch 2, 2021
The Importance of Continuity of Operations Plans for Gene Therapy Manufacturers
By: James Zoshak The COVID-19 pandemic has added increased risk and uncertainty to gene therapy…
CertaraFebruary 22, 2021
Why Consistency in Patient Safety Narratives is Crucial
“You would not be able to tell 40 different writers were authoring these. It looked…
CertaraFebruary 9, 2021
RAPS Sponsored Webinar: Efficiency and Technology Pave the Way for the New Age of Narrative Writing
Narratives are an integral part of medical writing. Sponsors sometimes need to prepare large…
CertaraFebruary 8, 2021
Regulatory submissions and transactions with Health Canada
By Robert Labriola We’ve seen recent trends and activity with regards to pharmaceutical regulatory submissions…
CertaraNovember 19, 2020
Stay on Track and Get Some Sleep: Marketing Application Best Practices
Without careful execution and the ability to navigate unexpected challenges, marketing application submissions are prone…
CertaraOctober 7, 2020
