Collation of Appendices and relevant documents
Formatting as per global submission requirements/ client specific templates and metadata checks
Submission ready checks including hyperlinking and formatting
eCTD compliant documents like CSRs, IBs, Protocols
Utilization of ISI Toolbox, TRS Toolbox, Acrobat ProDC, TRS Writer
Data consistency, integrity, accuracy checks and style guide compliance
Dedicated and expert Quality Control group capable of quality check for any and all types of Regulatory Medical Writing Documents
Sole partner for Quality Control for TAs like Immunology, Oncology, and Neuroscience for a sponsor
Customized QC checklists for every type of document
Successfully undergone multiple audits by major clients, with no major or critical findings reported
Functionalities of Our AI Driven Tool
Inbuilt CSR template (ICH E3 guidelines, TransCeralate)
Provision of automatically copying the relevant data from the protocol and other source data
End to end workflow (review, QC, editing and approval) designed in the tool
Interactive Dashboards
Audit Trail
21 CFR Part 11 Compliance