Description

The ORA requires a subscription for StartingPoint Common Technical Document (CTD) authoring templates, training, and maintenance to facilitate standardized authoring and reviewing of documents intended for regulatory submissions to the FDA. The objective is to increase writing efficiency, maintain formatting consistency, and ensure compliance with FDA and International Council for Harmonisation (ICH) standards.

Classification

Place of Performance

Contracting Office

Contacts

Attachments (2)

• Attachment 1
• Attachment 2