tranScrip has extensive capabilities to support successful regulatory submissions and approvals, whether it be first time applications, renewals, or label extensions.
tranScrip’s Regulatory team has worked on all stages of projects ranging from First-in-Man through to submissions for regulatory approval and subsequent variations. tranScrip has extensive experience in exploring creative regulatory strategies with health authorities to streamline the development programmes. Our geographical experience covers, FDA, EMA and PMDA.
Understanding ever-changing regulatory demands and harnessing new regulatory initiatives are important for optimal drug development.
The services that tranScrip provides include, but are not limited to:
- Preparation of CTDs and defence of MAAs/NDAs
- Preparation of Paediatric Investigational Plans (PIPs)
- Preparation of Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS)
- Preparation and defence of Orphan Designation Applications
- Label maintenance
- Support to regulatory scientific advice meetings (FDA, EMA, national agencies)
This case study demonstrates tranScrip’s role in achieving a label indication outside of usual regulatory guidance.
A biotech company sought to register an antibiotic for an indication that was not considered acceptable by EU regulatory guidance, using a single small clinical trial in a condition of high medical need.
tranScrip undertook the preparation of clinical sections of the MAA based on the reanalysis of the data package previously submitted to FDA, maintained a close dialogue with agency assessors and key opinion leaders to champion the need in this indication and followed the registration process throughout including support for oral hearing.
The desired label indication was achieved.