Regulatory writers lead the development of high-quality regulatory documents by working incollaboration with colleagues across multiple functions. Document development is a multistep processwith the regulatory writer acting as project leader. This article describes each of the stages of theprocess and suggests best practices for achieving timely project completion and document delivery.
Every FDA Advisory Committee meeting is unique, and the Cellular, Tissue, and Gene Therapies Advisory Committee meeting that took place on April 15, 2021 was not any different. The agenda included discussion of a biologics license application (BLA) for donislecel (purified allogeneic deceased donor pancreas derived Islets of Langerhans) for the treatment of brittle Type … Continued
Expands global reach and deepens regulatory expertise PRINCETON, NJ.— June 10, 2021– Certara, Inc., the global leader in biosimulation, today announced the acquisition of Insight Medical Writing, based in Oxford in the United Kingdom. Financial terms of the transaction were not disclosed. Founded in 2002, Insight Medical Writing offers regulatory services and medical writing. Its … Continued
The European Commission (EC) officially published the EU In Vitro Diagnostic Regulation (IVDR) 2017/746 in the Official Journal of the European Union (OJEU) 05 May of 2017, which came into force on 25 May 2017. The deadline for compliance is 26 May 2022, and there has been no indication that it will be extended. Manufacturers … Continued
Creating submission-ready regulatory documents that are consistent in presentation, appropriate in content, and formatted to be eCTD compliant the first time comes with its unique challenges. To address these challenges, Certara Synchrogenix paired its technical experts with its regulatory writers and editors to create a comprehensive eCTD authoring template suite. In this webinar, we provide … Continued
If you’ve heard about eCTD authoring template suites before, but you’re not sure what they do or whether they would be beneficial to your pharmaceutical company or CRO, you’ve come to the right place. Here I will explain what an authoring template suite is, and how it can improve efficiency among your writers and regulatory … Continued
There are common themes driving how quickly you can get from your last database lock (DBL) to submission of your marketing application. Speaking from first-hand experience across more than 50 marketing submissions, Synchrogenix regulatory science experts will demonstrate how, through thorough planning, you can improve and shorten your speed to drug submission. Speakers Anjana Bose, … Continued
