
Regulatory Writing Page
Our regulatory writing services offer expertly crafted, high-quality documents for drug development, ensuring compliance and timely submissions.
Our regulatory writing services offer expertly crafted, high-quality documents for drug development, ensuring compliance and timely submissions.
Publish, validate, and review your eCTD submissions with GlobalSubmit eCTD Software, eliminating risk and expediting regulatory acceptances.
Navigate regulatory complexities with expert support for submissions, compliance, and strategies to expedite approvals.
Included with Phoenix Hosted, Certara’s Integral equips PK scientists with an API-enabled data repository supporting both GXP and non-GxP studies.
Certara’s QSP modeling software enables modelers and scientists to predict drug efficacy and safety utilizing mathematical modeling and virtual trials.
Pirana provides a collaborative environment for managing and executing pharmacometric workflows, fully compatible with RsNLME.
Virtual Bioequivalence (VBE) is when bioequivalence of generic is demonstrated using modeling and simulation in lieu of clinical studies