Everything you need to know about ILAP 2.0
This white paper share’s key insights on the relaunch of MHRA’s Innovative Licensing and Access…
CertaraMay 19, 2025
Protect Confidential Information in Investigational Drug Submissions
March 20, 2025 Health regulatory agencies require pharmaceutical companies to protect study participants’ personal information…
CertaraMarch 20, 2025
Safety of combined long-acting injectable cabotegravir and long-acting injectable rilpivirine in virologically suppressed adolescents with HIV (IMPAACT 2017/MOCHA): a phase 1/2, multicentre, open-label, non-comparative, dose-finding study
The IMPAACT 2017/MOCHA study, a phase 1/2 multicenter trial across five countries, assessed the safety,…
CertaraMarch 20, 2025
EU CTIS: Europe’s New Clinical Trial Information System
The EU CTIS is now fully implemented, replacing EudraCT as the central hub for clinical…
CertaraFebruary 10, 2025
Anonymization vs. Redaction of Clinical Trial Data
January 17, 2025 The vernacular for disclosing pharmaceutical clinical trial results to the public may…
CertaraJanuary 17, 2025
Helping Sponsor Meet EMA Policy 0070 Requirements
The European Medicines Agency’s Policy on the Publication of Clinical Data for Medicinal Products for…
CertaraJanuary 7, 2025
Streamlining the Preparation of 1-Year and 2-Year PSURs
We explore how we helped one client deliver a last-minute addition to a Periodic Safety…
CertaraDecember 18, 2024
Delivering High-Quality, Timely Responses to EMA Safety Queries
A pharmaceutical company approached us for support with eight safety-related queries from the European Medicines…
CertaraDecember 12, 2024
CMC Writing Support Helps Client Lift Clinical Hold
In drug development, Chemistry, Manufacturing, and Controls (CMC) regulatory writing plays a pivotal role in ensuring the…
CertaraDecember 10, 2024
A Medical Writer’s Guide to Collaborative Authoring
Once upon a time, regulatory writing for drug development programs followed a scheduled routine and…
CertaraNovember 22, 2024
