Electronic Common Technical Document (eCTD)


• eCTDs are the end-product of the long and expensive clinical development process, and are the ultimate challenge in writing clinical documentation.

• ClinScript has extensive experience in preparing dozens of CTD/eCTD submissions, from straightforward local variations to complex global submission dossiers for multiple indications.

• Our clients appreciate ClinScript’s proactive involvement in ensuring that all aspects of the clinical development program are appropriately synthesized in a reviewer-friendly manner.

• ClinScript meets deadlines – a vital factor in successful and timely drug approvals.