Offerings

• Document Planning, Authoring, review and approval • Regulatory submission assembly and publishing • Regulatory submission delivery & tracking • Agency review and approval • Post approval follow-up • eCTD Submissions, eCTD 4.0 Consulting & Support • Nees Submissions • Paper Submissions • CSR- Report Level Publishing • Document Formatting Services • Archiving Submission Data • CDISC Legacy Data Conversions • Regulatory Data Migration • Publishing Consulting Services • Automation Services - Regulatory Submissions QC, Document Level Publishing

All activities that establish the submission plan, identify submission components, roles and responsibilities and promote an understanding of associated processes e.g.: Submission Planning and Management Team (SPMT) activities which promote emphasis on global participation to optimize harmonization of documents. • Submissions Management • Regulatory Operations • Content Planning