Operational Support Services
We offer a broad range of services, including:
-
Submission planning (TOC development)
-
Submission timeline forecasting (Timeline development)
-
Submission project management (Executing Submission TOC and Timeline)
-
Document word formatting & PDF publishing
-
Submission compilation (using submission-ready documents)
-
Submit a submission through ESG on behalf of the client.
-
Submission management (end-to-end)
COMPILING CLINICAL STUDY REPORTS
-
TFL Preparation
-
In-text Hyperlinks
-
External Hyperlinks
-
Bookmarks
-
OCR
-
Optimization
-
Submission-ready CSR package
FORMATTING MS WORD DOCUMENTS
-
Heading styles
-
Tables & Figures
-
Table of Contents
-
List of Tables & Figures
-
Citations & Reference Lists
-
Footnotes
-
Headers & Footers
-
Margin settings
-
Fonts & Styles
PUBLISHING PDF DOCUMENTS
-
In-text Hyperlinks
-
Bookmarks
-
OCR
-
Optimization
-
Submission-ready PDF
Document Processing Services
SUPPORTED APPLICATION TYPES
-
IND
-
NDA
-
BLA
-
HC NDS
-
EU MAA
-
PIP, Scientific Advices, VHP
SUPPORTED SUBMISSION TYPES
-
Original IND, NDA, BLA, NDS, MAA
-
BLA and NDA Supplements
-
Amendments and Maintenance Submissions
-
IND Safety Reports
-
IND New Investigators
-
VHP Submissions to EMA
-
Initial and subsequent PIP andScientific Advice Submissions
DELIVERABLE
-
Validated and Submission ready Sequences and Outputs
-
Dispatch through FDA and EMA ESG if required
-
Archival copy of Sequences and Outputs
eCTD and NeeS Publishing Services
Important Health Authority Dates
May 5, 2017: New Drug Applications (NDAs), Abbreviated NDAs (ANDAs), and Biologics License Applications (BLAs), must be submitted using eCTD format.
May 5, 2018: Commercial Investigational New Drug Applications (INDs) and Master Files must be submitted using eCTD format.
